0A4F4F9BD490A749D5437F821CF06DF1
Instructions on Manner of Reporting on Safety in the Framework of Clinical Trials (2016)
http://www.almbih.gov.ba/_doc/upustva-vodici/uputstvo_o_nacinu_izvjestavanja_o_sigurnosti.pdf
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Health / Drug Usage
Searching for indicator drug:
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p.(None): INSTRUCTIONS ON THE METHOD OF SAFETY REPORTING WITHIN THE CLINICAL TEST
p.(None): This guide defines how to collect, check, and report adverse events and adverse events
p.(None): (side effects) that occur in clinical trials.
p.(None): METHOD OF NOTIFYING TESTING ORDERS FROM RESEARCHERS ABOUT ADVERSE EVENTS AND SERIOUS ADVERSE
p.(None): EVENTS
p.(None): Adverse event is an adverse event that occurred during the period of drug administration and for which a cause-and-effect relationship with
p.(None): the use of the drug does not have to be proven. Unwanted experience is any unintended and unwanted sign
p.(None): (eg, abnormal laboratory findings), a symptom or disease, temporally associated with the administration of the drug.
p.(None): A serious adverse event1 is an adverse event that results in death, immediate life threat,
p.(None): disability, hospital treatment, extension of existing hospital treatment, congenital anomalies, or defect
p.(None): discovered at birth, or requires intervention to prevent the aforementioned consequences.
p.(None): The researcher records and records adverse events or laboratory abnormalities that are planned for the clinical setting
p.(None): tests listed as crucial to the safety assessment and shall be reported to the contracting authority
p.(None): in accordance with the notification requirements and within the time limits set by the clinical trial plan.
p.(None): The researcher records and records all adverse events unless otherwise provided by the clinical plan
p.(None): testing. The researcher informs the research client of any serious adverse events that occur
p.(None): to the respondent treated by the investigator during the clinical trial, unless otherwise provided by the plan
p.(None): clinical trial.
p.(None): The researcher informs the client without undue delay and within 24 hours of finding out about them
p.(None): trials on serious adverse events, unless, for specific adverse events, a clinical plan
p.(None): no urgent reporting was found to be necessary. If necessary, the researcher shall send to the client
p.(None): a follow up report to enable the testing contractor to determine if it is affected
p.(None): a serious adverse event on the benefit-risk relationship of the clinical trial.
p.(None): 1 These consequences must be taken into account at the time of the event. For example, in relation to a life-threatening event, it does
p.(None): refers to an event in which the respondent was at risk of death at the time of the event; it does not refer to an event that
p.(None): it can hypothetically cause death if it is more severe.
p.(None): In cases where reporting is not required immediately, the investigator shall submit the report as appropriate
p.(None): of the timeframe, taking into account the specifics of the trial and the severity of the adverse event, according to
p.(None): the deadlines set out in the protocol or booklet for researchers.
p.(None): After completing the clinical trial, the researcher should not actively monitor the subjects he / she treated at
p.(None): with respect to adverse events, unless otherwise specified in the clinical trial plan.
p.(None): If the researcher detects serious adverse events that may be causally related to the drug used in
p.(None): clinical trial, and occur after the end of the clinical trial in the subjects treated by the researcher,
p.(None): the investigator informs the trial client of a serious adverse event without undue delay.
p.(None): The test client shall keep detailed records of all adverse events investigated by the investigator
p.(None): informed.
p.(None): ADVERSE REACTIONS OF THE MEDICINAL PRODUCT AND ASSESSMENT OF THE INCURRENCE, CAUSATION AND EXPECTATION
p.(None): A side effect (side effect) of a drug is any adverse and unintentionally triggered reaction that may occur with
p.(None): therapeutic dose of the drug. The definition also covers errors in the administration of the drug and the use of the drug beyond the scope of what
p.(None): is provided for in the clinical trial plan, including misuse and misuse of the product.
p.(None): A serious side effect (side effect) of a drug is a harmful and inadvertently triggered reaction to
p.(None): medicine resulting in death, immediate life threatening, disability, hospital treatment (if not
p.(None): either necessary), extension of hospital treatment or congenital anomaly, or birth defect.
p.(None): An unexpected side effect (side effect) of a drug is that of a drug whose nature,
p.(None): weight2 or outcome are not known or described in the Summary of Product Characteristics or in the Research Leaflet for
p.(None): drugs that are in clinical trials and cannot be expected based on known pharmacological properties of the drug.
p.(None): It is the responsibility of the test client to ensure that all reported adverse events are cumulative,
p.(None): - have a reasonable possibility of causation with the product under test (IMP)
p.(None): - are "serious" and
p.(None): - are "unexpected".
p.(None): 2 The term “weight” is used here to describe the intensity of a particular event. This should be different from the term
p.(None): "Serious."
p.(None): ASSESSMENT OF THE INCIDENCE
p.(None): An assessment of whether an event is serious is usually made by the investigator's rapporteur.
p.(None): CAUSATION ASSESSMENT
p.(None): In determining whether an adverse event is a side effect, consideration is given to whether there is a viable possibility
p.(None): establishing a causal link between the event and the investigational drug based on an analysis of the available evidence.
p.(None): The assessment of whether there is a reasonable possibility of a causal relationship is usually made by the researcher.
p.(None): In the absence of information provided by the investigator-rapporteur on causality, the investigator shall consult
p.(None): with the investigating rapporteur and encourages him to express his views on the matter. Investigator
p.(None): does not diminish the value of the causality assessment given by the researcher. If the contracting authority does not agree with
p.(None): the investigator's causality assessment reports the unexpected serious side effects of both.
p.(None): ASSESSMENT / EXPECTATION ASSESSMENT
p.(None): When determining whether an adverse event is unexpected, it considers whether the event adds significant information about
p.(None): specificity, increase in frequency or severity of a known serious adverse reaction that has already been documented.
p.(None): The expectation of adverse effects is determined by the client of the test in the reference safety information.
p.(None): Expectancy is determined on the basis of previously observed events with the active substance and not on the basis of expected events
p.(None): pharmacological properties of the drug or events related to the respondent's disease.
p.(None): The safety reference information provided in the Product Features Summary (SmPC) or brochure for
p.(None): researchers (IB). A cover letter indicates where the reference safety information is located
p.(None): within the documentation regarding the request. Investigator of the test as a reference security
p.(None): the information selects the summary of product characteristics that is most appropriate for safety
p.(None): respondents.
p.(None): Reference safety information may change during the conduct of a clinical trial. For reporting purposes
p.(None): of the unexpected serious side effects the version of the reference safety information that is
p.(None): valid at the time of the occurrence of unexpected serious adverse reactions. Therefore, changing the security reference
p.(None): the information influences the number of side effects to be reported as suspected unexpected serious side effects.
p.(None): The expectation assessment is usually done by the contracting authority. If the investigating rapporteur has provided
p.(None): expectation information, the contracting authority shall take them into account.
p.(None): METHOD OF NOTIFICATION OF THE AGENCY AND ETHICAL COMMITTEES BY THE CONTRACTING AUTHORITY ABOUT SUSPECTING Unexpected DANGEROUS
p.(None): SIDE EFFECTS
p.(None): 06.35 Suspected Unexpected Serious Adverse Reactions -SUSAR
p.(None): The client of the clinical trial conducted in BiH submits all relevant information on
p.(None): suspects the following unexpected serious side effects:
p.(None): • any suspected unexpected serious adverse reactions to the investigational drugs that occur
p.(None): during that clinical trial;
p.(None): • any suspected unexpected serious side effects associated with the same active substance, regardless of
p.(None): pharmaceutical form and strength or indication under investigation, u
p.(None): investigational drug and occurring in a clinical trial conducted (exclusively) outside BiH, if clinical
p.(None): testing commissioned by:
p.(None): - that client; or
p.(None): - different client who is part of the same parent company as the client clinical
p.(None): trials, or who jointly develops a drug with the clinical trial client3
p.(None): on the basis of a formal agreement;
p.(None): • any suspected unexpected serious side effects of the study drug that occur in any of the subjects in
p.(None): the clinical trial, to be determined or to be seen by the client at the end of the clinical trial.
p.(None): Deadline for notifying the Agency and the Ethics Committees of suspected unexpected
p.(None): The serious side effect was determined depending on the severity of the side effect and amounts to:
p.(None): a) in the case of life-threatening or life-threatening suspicion, of unexpected serious adverse reactions occurring during that period;
p.(None): clinical trial in BiH as soon as possible and in any case not later than seven days after
p.(None): the client learns of a side effect; if necessary, ensure timely reporting, the contracting authority
p.(None): may submit an initial incomplete report followed by a full follow-up report,
p.(None): within eight days at the latest;
p.(None): b) in the case of non-lethal SUSARs or suspected unexpected serious, non-life-threatening side effects which
p.(None): occur during that clinical trial in BiH, not later than 15 days after the client becomes aware of a side effect;
p.(None): c) in case of suspected unexpected serious adverse reactions occurring during that clinical trial in
p.(None): BiH, which were initially considered non-lethal and life-threatening and turned out to be deadly or
p.(None): life-threatening, as soon as possible, and in any case not later than seven days after
p.(None): the client learns that the side effect is deadly or life-threatening;
p.(None): d) in case of suspected unexpected serious adverse reactions occurring during that clinical trial outside
p.(None): BiH, even in case of suspected unexpected serious side effects related to the same active substance, regardless
p.(None): to pharmaceutical form and strength or
p.(None): 3 Obtaining the investigational drug or safety information to a prospective potential marketing authorization holder
p.(None): marketing is not considered a joint development.
p.(None): the indication being investigated, in the investigational drug, and which appear in the clinical trial being conducted
p.(None): (exclusively) outside BiH, if the clinical trial was commissioned by that client or by a different client
p.(None): of the same parent company, the client of the clinical trial is obliged to the Agency at least once every six months
p.(None): to submit a linear list of all SUSARs for the observed period, with the accompanying clinical client report
p.(None): examinations on major security issues.
p.(None): SUSAR MONITORING REPORT
p.(None): If the initial report of suspected unexpected serious adverse reactions (fatal or life-threatening) is incomplete, (at
p.(None): example: if the contracting authority did not provide all the information within seven days), the contracting authority within
p.(None): an additional eight days submit a full report based on initial information.
p.(None): The countdown for submission of the initial report (day 0 = Di 0) starts as soon as the contracting authority receives it
p.(None): information containing minimum reporting criteria.
p.(None): If the trial contractor receives significant new information on a case already recorded,
p.(None): the countdown starts again from zero, that is, when the new information is received. This information is provided in
p.(None): follow-up report within 15 days.
p.(None): If the initial report of suspected unexpected serious adverse reaction initially considered to be
p.(None): not deadly or life-threatening, but turned out to be deadly or life-threatening,
p.(None): incomplete, it should be reported as soon as possible, but within seven days of learning that the side effect is
p.(None): deadly or life-threatening. The contracting authority shall submit a completed report within an additional eight days.
p.(None): In cases where SUSAR, which was initially considered not to be life-threatening or life-threatening, turns out to be
p.(None): lethal or life-threatening, a joint report shall be drawn up if the initial report has not yet been submitted.
p.(None): DETERMINING THE IDENTITY OF THE ALLOCATED TREATMENT
p.(None): The researcher discovers the identity of the assigned treatment of the subjects while conducting the clinical
p.(None): examinations only if identity disclosure is relevant to the respondent's safety.
p.(None): When reporting to the Agency and the Ethics Committees on SUSAR, the client reveals the identity of the treatment
p.(None): assigned to the respondents to whom SUSAR refers.
p.(None): If there is a possible suspicion of an unexpected serious side effect, only the contracting authority shall disclose
p.(None): identity only for that respondent. The drug still remains masked to other persons responsible for
p.(None): continuous conduct of clinical trials (such as administration, monitors,
p.(None): researchers) and those persons responsible for analyzing the data and interpreting the results after completion
p.(None): clinical trial, such as biometric personnel.
p.(None): The information disclosed is available only to those persons who are required to participate in the security reporting to the
p.(None): clinical trials or persons who continuously perform safety assessments during the clinical trial.
p.(None): However, if for clinical trials conducted in diseases with high morbidity or high
p.(None): mortality, where the ultimate indicators of efficacy could also be the suspicion of unexpected serious side effects, or
p.(None): when the ultimate indicator of clinical trial effectiveness is death or other
p.(None): A "serious" outcome (which could potentially be reported as suspected unexpectedly serious
p.(None): side effect), systematic disclosure of the identity of the study drug could compromise the integrity of the clinical
p.(None): testing. In these and similar circumstances, the trial client points out in the clinical trial plan which ones are serious
p.(None): events should be treated as disease-related and not susceptible to systematically revealing the identity of the subject
p.(None): drug and accelerated reporting.
p.(None): If, after discovering the identity of an investigational drug for an event, it turns out to be SUSAR, the rules apply
p.(None): for reporting suspected unexpected serious side effects.
p.(None): SUSAR RELATED TO ACTIVE COMPARATOR OR PLACEBO
p.(None): Comparators and placebo are IMPs. Therefore, the same requirements for SUSARs associated with an active comparator apply
p.(None): reporting as for the IMP test. Placebo-related events do not usually meet the criteria for SUSAR
p.(None): and thus for emergency reporting. However, where SUSARs are associated with placebo (eg reaction due to ancillary
p.(None): substance or impurity), the contracting authority should report such cases.
p.(None): ANNUAL REPORTING OF SAFETY TENDERER
p.(None): With regard to the medicines tested (except for placebo), the study sponsor is obliged to submit annually
p.(None): a report to the Agency and the Ethics Committees on the safety of each study drug used in the clinical trial
p.(None): to which he is the client.
p.(None): In the case of a clinical trial involving the use of more than one study drug,
p.(None): the trial contracting authority may, if provided for in the clinical trial plan, submit one report on
p.(None): safety for all investigational drugs used in that clinical trial.
p.(None): The annual report contains only aggregate and anonymous data.
p.(None): The annual reporting obligation begins with the first approval of the clinical trial and ends with the completion of the last
p.(None): clinical trial conducted by the client with the investigational drug in BiH.
p.(None): The report in the appendix contains the security reference information in effect at the beginning of the period of which
p.(None): is being reported.
p.(None): The security reference information in effect at the beginning of the reporting period serves as a
p.(None): reference safety information during the reporting period.
p.(None): If the reference security information changes significantly during the reporting period, then
p.(None): the changes are stated in the annual safety report. Moreover, in this case the security reference is revised
p.(None): the information is submitted in addition to the report, with the security reference information in force at
p.(None): the beginning of the reporting period. Despite the change in the reference security information, the reference
p.(None): security information in place at the beginning of the reporting period serves as a reference
p.(None): security information during the reporting period.
p.(None): Details on annual security reporting, including rules on identity disclosure,
p.(None): it is prescribed in the ICH E2F - Development Safety Update Report 'DSUR' guidelines.
p.(None): POSTMARKETING CLINICAL STUDIES SAFETY NOTIFICATION
p.(None): Safety notification from post-marketing clinical studies is done in accordance with the Rules of Procedure
p.(None): reporting, collecting and monitoring adverse drug reactions ("Official Gazette of Bosnia and
p.(None): Herzegovina ", No. 58/12).
p.(None): METHOD OF SUBMISSION OF SECURITY INFORMATION IN CLINICAL TRIALS
p.(None): Who submits to the Agency the following documents related to clinical trials: suspected serious unexpected side effects
p.(None): (SUSAR), SUSAR Linear Lists, Development Safety Update Report
p.(None): - DSUR) and other safety information related to the drug in the clinical trial?
p.(None): The clinical trial client or the representative of the clinical trial client shall submit it to the Agency
p.(None): clinical trial documents. If the client of the clinical trial is not based in BiH, as
p.(None): the representative must be authorized by a natural or legal person established in BiH.
p.(None): How to submit safety-related documents in clinical trials:
p.(None): • SUSAR registration is done through the Licensee's Adverse Reaction Form, which can be found at
p.(None): the Medicines Agency website: www.almbih.gov.ba or through the CIOMS-I form, with the accompanying document to which
p.(None): to which the following should be indicated:
p.(None): a) the Agency's protocol number;
p.(None): b) the name of the clinical trial;
p.(None): c) the designation of the clinical trial plan;
p.(None): d) information on the investigator-rapporteur;
p.(None): e) suspected unexpected serious adverse reaction;
p.(None): f) possible investigational drug (including name-code number of the active substance);
p.(None): g) causality assessment.
p.(None): The completed form with the accompanying act can be submitted to the Agency in one of the following ways:
p.(None): - by mail, to the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina, Veljka
p.(None): Mlađenovica bb, Banja Luka;
p.(None): - by fax: 051 / 450-301;
p.(None): - by e-mail (e-mail: klinicka@almbih.gov.ba)
p.(None): • The linear list shall be submitted by electronic mail on CD with the accompanying document to be indicated
p.(None): name and designation of clinical trial plan (s) with study drug in BiH.
p.(None): • The DSUR shall be submitted by electronic mail on a CD, accompanied by a statement stating the name and
p.(None): the designation of the clinical trial plans (s) with the study drug in BiH.
p.(None): ADVERSE REACTIONS OF MEDICINES NOT RECEIVED AS SUSAR
p.(None): In particular, there is no need for testing contractors to report as SUSAR (but may require some
p.(None): other actions as described below)
p.(None): • side effects not related to IMP but to additional drugs (non-IMP) and not resulting from interactions with IMP;
p.(None): • SUSAR in a non-sponsor clinical study;
p.(None): • adverse reactions to medicines occurring outside BiH beyond the clinical trial, exclusively used as an IMP in
p.(None): BIH.
p.(None): NOTIFICATION OF ADVERSE REACTIONS RELATED TO ADDITIONAL MEDICINES (NON-IMP)
p.(None): Safety notification regarding additional medicines is done in accordance with the Regulations on the method of reporting,
p.(None): of collecting and monitoring adverse drug reactions (Official Gazette of Bosnia and Herzegovina, No. 58/12)
p.(None): .
p.(None): OTHER IMPORTANT SAFETY INFORMATION THAT DOES NOT COVER SUSAR - OTHER MEASURES
p.(None): Events may occur during a clinical trial that do not fall within the definition of SUSAR and are therefore not subject to
p.(None): reporting requirements for SUSARs, although they may be relevant in terms of respondent safety.
p.(None): For example, new developments related to the study or development of IMP may affect security
p.(None): respondents, such as:
p.(None): - A serious adverse event that could be related to study procedures and that could modify implementation
p.(None): studies;
p.(None): - Significant risk to the population, such as lack of efficiency in the IMP used for
p.(None): treatment of a life-threatening illness;
p.(None): - A major safety breakthrough from a recently completed animal study (such as
p.(None): carcinogenicity);
p.(None): - Suspension of the study for safety reasons, if the study is conducted with the same examinee
p.(None): a medicinal product in another country by the same sponsor;
p.(None): - Recommendations of the DSMB (Data and Safety Monitoring Board), if any, where relevant to the safety of the respondents.
p.(None): These events / observations may not be reported as SUSAR, but they may require others
p.(None): actions such as:
p.(None): - Emergency security measures and their notifications;
p.(None): - Significant amendments;
p.(None): - Early interruption of testing.
...
p.(None): The deadline for notification of suspected unexpected serious adverse reactions is set depending on
p.(None): of the severity of the side effect, and is:
p.(None): a) in the case of life-threatening or life-threatening suspicion, of unexpected serious adverse reactions occurring during that period;
p.(None): clinical trial in BiH as soon as possible and in any case not later than seven days after
p.(None): the client learns of a side effect; if necessary, ensure timely reporting, the contracting authority
p.(None): may submit an initial incomplete report followed by a full follow-up report,
p.(None): within eight days at the latest;
p.(None): b) in the case of non-lethal SUSARs or suspected unexpected serious, non-life-threatening side effects which
p.(None): occur during that clinical trial in BiH, not later than 15 days after the client becomes aware of a side effect;
p.(None): c) in case of suspected unexpected serious adverse reactions occurring during that clinical event
p.(None): interrogations in BiH, which were initially considered non-lethal and life-threatening, and for which
p.(None): they turn out to be deadly or life-threatening, as soon as possible and in any case the furthest away
p.(None): within seven days after the client learns that the side effect is deadly or dangerous
p.(None): life.
p.(None): The information should be concise and practical. Therefore, whenever possible, information on SUSARs should be consolidated
p.(None): in the form of a linear list of SUSARs over periods determined by the nature of the research project / clinical development project and
p.(None): volume of SUSARs generated. The linear list should be accompanied by a concise review of the development security profile
...
Searching for indicator substance:
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p.(None): 2 The term “weight” is used here to describe the intensity of a particular event. This should be different from the term
p.(None): "Serious."
p.(None): ASSESSMENT OF THE INCIDENCE
p.(None): An assessment of whether an event is serious is usually made by the investigator's rapporteur.
p.(None): CAUSATION ASSESSMENT
p.(None): In determining whether an adverse event is a side effect, consideration is given to whether there is a viable possibility
p.(None): establishing a causal link between the event and the investigational drug based on an analysis of the available evidence.
p.(None): The assessment of whether there is a reasonable possibility of a causal relationship is usually made by the researcher.
p.(None): In the absence of information provided by the investigator-rapporteur on causality, the investigator shall consult
p.(None): with the investigating rapporteur and encourages him to express his views on the matter. Investigator
p.(None): does not diminish the value of the causality assessment given by the researcher. If the contracting authority does not agree with
p.(None): the investigator's causality assessment reports the unexpected serious side effects of both.
p.(None): ASSESSMENT / EXPECTATION ASSESSMENT
p.(None): When determining whether an adverse event is unexpected, it considers whether the event adds significant information about
p.(None): specificity, increase in frequency or severity of a known serious adverse reaction that has already been documented.
p.(None): The expectation of adverse effects is determined by the client of the test in the reference safety information.
p.(None): Expectancy is determined on the basis of previously observed events with the active substance and not on the basis of expected events
p.(None): pharmacological properties of the drug or events related to the respondent's disease.
p.(None): The safety reference information provided in the Product Features Summary (SmPC) or brochure for
p.(None): researchers (IB). A cover letter indicates where the reference safety information is located
p.(None): within the documentation regarding the request. Investigator of the test as a reference security
p.(None): the information selects the summary of product characteristics that is most appropriate for safety
p.(None): respondents.
p.(None): Reference safety information may change during the conduct of a clinical trial. For reporting purposes
p.(None): of the unexpected serious side effects the version of the reference safety information that is
p.(None): valid at the time of the occurrence of unexpected serious adverse reactions. Therefore, changing the security reference
p.(None): the information influences the number of side effects to be reported as suspected unexpected serious side effects.
p.(None): The expectation assessment is usually done by the contracting authority. If the investigating rapporteur has provided
p.(None): expectation information, the contracting authority shall take them into account.
p.(None): METHOD OF NOTIFICATION OF THE AGENCY AND ETHICAL COMMITTEES BY THE CONTRACTING AUTHORITY ABOUT SUSPECTING Unexpected DANGEROUS
p.(None): SIDE EFFECTS
p.(None): 06.35 Suspected Unexpected Serious Adverse Reactions -SUSAR
p.(None): The client of the clinical trial conducted in BiH submits all relevant information on
p.(None): suspects the following unexpected serious side effects:
p.(None): • any suspected unexpected serious adverse reactions to the investigational drugs that occur
p.(None): during that clinical trial;
p.(None): • any suspected unexpected serious side effects associated with the same active substance, regardless of
p.(None): pharmaceutical form and strength or indication under investigation, u
p.(None): investigational drug and occurring in a clinical trial conducted (exclusively) outside BiH, if clinical
p.(None): testing commissioned by:
p.(None): - that client; or
p.(None): - different client who is part of the same parent company as the client clinical
p.(None): trials, or who jointly develops a drug with the clinical trial client3
p.(None): on the basis of a formal agreement;
p.(None): • any suspected unexpected serious side effects of the study drug that occur in any of the subjects in
p.(None): the clinical trial, to be determined or to be seen by the client at the end of the clinical trial.
p.(None): Deadline for notifying the Agency and the Ethics Committees of suspected unexpected
p.(None): The serious side effect was determined depending on the severity of the side effect and amounts to:
p.(None): a) in the case of life-threatening or life-threatening suspicion, of unexpected serious adverse reactions occurring during that period;
p.(None): clinical trial in BiH as soon as possible and in any case not later than seven days after
p.(None): the client learns of a side effect; if necessary, ensure timely reporting, the contracting authority
p.(None): may submit an initial incomplete report followed by a full follow-up report,
p.(None): within eight days at the latest;
p.(None): b) in the case of non-lethal SUSARs or suspected unexpected serious, non-life-threatening side effects which
p.(None): occur during that clinical trial in BiH, not later than 15 days after the client becomes aware of a side effect;
p.(None): c) in case of suspected unexpected serious adverse reactions occurring during that clinical trial in
p.(None): BiH, which were initially considered non-lethal and life-threatening and turned out to be deadly or
p.(None): life-threatening, as soon as possible, and in any case not later than seven days after
p.(None): the client learns that the side effect is deadly or life-threatening;
p.(None): d) in case of suspected unexpected serious adverse reactions occurring during that clinical trial outside
p.(None): BiH, even in case of suspected unexpected serious side effects related to the same active substance, regardless
p.(None): to pharmaceutical form and strength or
p.(None): 3 Obtaining the investigational drug or safety information to a prospective potential marketing authorization holder
p.(None): marketing is not considered a joint development.
p.(None): the indication being investigated, in the investigational drug, and which appear in the clinical trial being conducted
p.(None): (exclusively) outside BiH, if the clinical trial was commissioned by that client or by a different client
p.(None): of the same parent company, the client of the clinical trial is obliged to the Agency at least once every six months
p.(None): to submit a linear list of all SUSARs for the observed period, with the accompanying clinical client report
p.(None): examinations on major security issues.
p.(None): SUSAR MONITORING REPORT
p.(None): If the initial report of suspected unexpected serious adverse reactions (fatal or life-threatening) is incomplete, (at
p.(None): example: if the contracting authority did not provide all the information within seven days), the contracting authority within
p.(None): an additional eight days submit a full report based on initial information.
p.(None): The countdown for submission of the initial report (day 0 = Di 0) starts as soon as the contracting authority receives it
p.(None): information containing minimum reporting criteria.
p.(None): If the trial contractor receives significant new information on a case already recorded,
...
p.(None): when the ultimate indicator of clinical trial effectiveness is death or other
p.(None): A "serious" outcome (which could potentially be reported as suspected unexpectedly serious
p.(None): side effect), systematic disclosure of the identity of the study drug could compromise the integrity of the clinical
p.(None): testing. In these and similar circumstances, the trial client points out in the clinical trial plan which ones are serious
p.(None): events should be treated as disease-related and not susceptible to systematically revealing the identity of the subject
p.(None): drug and accelerated reporting.
p.(None): If, after discovering the identity of an investigational drug for an event, it turns out to be SUSAR, the rules apply
p.(None): for reporting suspected unexpected serious side effects.
p.(None): SUSAR RELATED TO ACTIVE COMPARATOR OR PLACEBO
p.(None): Comparators and placebo are IMPs. Therefore, the same requirements for SUSARs associated with an active comparator apply
p.(None): reporting as for the IMP test. Placebo-related events do not usually meet the criteria for SUSAR
p.(None): and thus for emergency reporting. However, where SUSARs are associated with placebo (eg reaction due to ancillary
p.(None): substance or impurity), the contracting authority should report such cases.
p.(None): ANNUAL REPORTING OF SAFETY TENDERER
p.(None): With regard to the medicines tested (except for placebo), the study sponsor is obliged to submit annually
p.(None): a report to the Agency and the Ethics Committees on the safety of each study drug used in the clinical trial
p.(None): to which he is the client.
p.(None): In the case of a clinical trial involving the use of more than one study drug,
p.(None): the trial contracting authority may, if provided for in the clinical trial plan, submit one report on
p.(None): safety for all investigational drugs used in that clinical trial.
p.(None): The annual report contains only aggregate and anonymous data.
p.(None): The annual reporting obligation begins with the first approval of the clinical trial and ends with the completion of the last
p.(None): clinical trial conducted by the client with the investigational drug in BiH.
p.(None): The report in the appendix contains the security reference information in effect at the beginning of the period of which
p.(None): is being reported.
p.(None): The security reference information in effect at the beginning of the reporting period serves as a
p.(None): reference safety information during the reporting period.
p.(None): If the reference security information changes significantly during the reporting period, then
...
p.(None): reporting, collecting and monitoring adverse drug reactions ("Official Gazette of Bosnia and
p.(None): Herzegovina ", No. 58/12).
p.(None): METHOD OF SUBMISSION OF SECURITY INFORMATION IN CLINICAL TRIALS
p.(None): Who submits to the Agency the following documents related to clinical trials: suspected serious unexpected side effects
p.(None): (SUSAR), SUSAR Linear Lists, Development Safety Update Report
p.(None): - DSUR) and other safety information related to the drug in the clinical trial?
p.(None): The clinical trial client or the representative of the clinical trial client shall submit it to the Agency
p.(None): clinical trial documents. If the client of the clinical trial is not based in BiH, as
p.(None): the representative must be authorized by a natural or legal person established in BiH.
p.(None): How to submit safety-related documents in clinical trials:
p.(None): • SUSAR registration is done through the Licensee's Adverse Reaction Form, which can be found at
p.(None): the Medicines Agency website: www.almbih.gov.ba or through the CIOMS-I form, with the accompanying document to which
p.(None): to which the following should be indicated:
p.(None): a) the Agency's protocol number;
p.(None): b) the name of the clinical trial;
p.(None): c) the designation of the clinical trial plan;
p.(None): d) information on the investigator-rapporteur;
p.(None): e) suspected unexpected serious adverse reaction;
p.(None): f) possible investigational drug (including name-code number of the active substance);
p.(None): g) causality assessment.
p.(None): The completed form with the accompanying act can be submitted to the Agency in one of the following ways:
p.(None): - by mail, to the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina, Veljka
p.(None): Mlađenovica bb, Banja Luka;
p.(None): - by fax: 051 / 450-301;
p.(None): - by e-mail (e-mail: klinicka@almbih.gov.ba)
p.(None): • The linear list shall be submitted by electronic mail on CD with the accompanying document to be indicated
p.(None): name and designation of clinical trial plan (s) with study drug in BiH.
p.(None): • The DSUR shall be submitted by electronic mail on a CD, accompanied by a statement stating the name and
p.(None): the designation of the clinical trial plans (s) with the study drug in BiH.
p.(None): ADVERSE REACTIONS OF MEDICINES NOT RECEIVED AS SUSAR
p.(None): In particular, there is no need for testing contractors to report as SUSAR (but may require some
p.(None): other actions as described below)
p.(None): • side effects not related to IMP but to additional drugs (non-IMP) and not resulting from interactions with IMP;
p.(None): • SUSAR in a non-sponsor clinical study;
p.(None): • adverse reactions to medicines occurring outside BiH beyond the clinical trial, exclusively used as an IMP in
p.(None): BIH.
p.(None): NOTIFICATION OF ADVERSE REACTIONS RELATED TO ADDITIONAL MEDICINES (NON-IMP)
p.(None): Safety notification regarding additional medicines is done in accordance with the Regulations on the method of reporting,
...
Health / Mentally Disabled
Searching for indicator disability:
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p.(None): INSTRUCTIONS ON THE METHOD OF SAFETY REPORTING WITHIN THE CLINICAL TEST
p.(None): This guide defines how to collect, check, and report adverse events and adverse events
p.(None): (side effects) that occur in clinical trials.
p.(None): METHOD OF NOTIFYING TESTING ORDERS FROM RESEARCHERS ABOUT ADVERSE EVENTS AND SERIOUS ADVERSE
p.(None): EVENTS
p.(None): Adverse event is an adverse event that occurred during the period of drug administration and for which a cause-and-effect relationship with
p.(None): the use of the drug does not have to be proven. Unwanted experience is any unintended and unwanted sign
p.(None): (eg, abnormal laboratory findings), a symptom or disease, temporally associated with the administration of the drug.
p.(None): A serious adverse event1 is an adverse event that results in death, immediate life threat,
p.(None): disability, hospital treatment, extension of existing hospital treatment, congenital anomalies, or defect
p.(None): discovered at birth, or requires intervention to prevent the aforementioned consequences.
p.(None): The researcher records and records adverse events or laboratory abnormalities that are planned for the clinical setting
p.(None): tests listed as crucial to the safety assessment and shall be reported to the contracting authority
p.(None): in accordance with the notification requirements and within the time limits set by the clinical trial plan.
p.(None): The researcher records and records all adverse events unless otherwise provided by the clinical plan
p.(None): testing. The researcher informs the research client of any serious adverse events that occur
p.(None): to the respondent treated by the investigator during the clinical trial, unless otherwise provided by the plan
p.(None): clinical trial.
p.(None): The researcher informs the client without undue delay and within 24 hours of finding out about them
p.(None): trials on serious adverse events, unless, for specific adverse events, a clinical plan
p.(None): no urgent reporting was found to be necessary. If necessary, the researcher shall send to the client
p.(None): a follow up report to enable the testing contractor to determine if it is affected
p.(None): a serious adverse event on the benefit-risk relationship of the clinical trial.
p.(None): 1 These consequences must be taken into account at the time of the event. For example, in relation to a life-threatening event, it does
p.(None): refers to an event in which the respondent was at risk of death at the time of the event; it does not refer to an event that
p.(None): it can hypothetically cause death if it is more severe.
...
p.(None): of the timeframe, taking into account the specifics of the trial and the severity of the adverse event, according to
p.(None): the deadlines set out in the protocol or booklet for researchers.
p.(None): After completing the clinical trial, the researcher should not actively monitor the subjects he / she treated at
p.(None): with respect to adverse events, unless otherwise specified in the clinical trial plan.
p.(None): If the researcher detects serious adverse events that may be causally related to the drug used in
p.(None): clinical trial, and occur after the end of the clinical trial in the subjects treated by the researcher,
p.(None): the investigator informs the trial client of a serious adverse event without undue delay.
p.(None): The test client shall keep detailed records of all adverse events investigated by the investigator
p.(None): informed.
p.(None): ADVERSE REACTIONS OF THE MEDICINAL PRODUCT AND ASSESSMENT OF THE INCURRENCE, CAUSATION AND EXPECTATION
p.(None): A side effect (side effect) of a drug is any adverse and unintentionally triggered reaction that may occur with
p.(None): therapeutic dose of the drug. The definition also covers errors in the administration of the drug and the use of the drug beyond the scope of what
p.(None): is provided for in the clinical trial plan, including misuse and misuse of the product.
p.(None): A serious side effect (side effect) of a drug is a harmful and inadvertently triggered reaction to
p.(None): medicine resulting in death, immediate life threatening, disability, hospital treatment (if not
p.(None): either necessary), extension of hospital treatment or congenital anomaly, or birth defect.
p.(None): An unexpected side effect (side effect) of a drug is that of a drug whose nature,
p.(None): weight2 or outcome are not known or described in the Summary of Product Characteristics or in the Research Leaflet for
p.(None): drugs that are in clinical trials and cannot be expected based on known pharmacological properties of the drug.
p.(None): It is the responsibility of the test client to ensure that all reported adverse events are cumulative,
p.(None): - have a reasonable possibility of causation with the product under test (IMP)
p.(None): - are "serious" and
p.(None): - are "unexpected".
p.(None): 2 The term “weight” is used here to describe the intensity of a particular event. This should be different from the term
p.(None): "Serious."
p.(None): ASSESSMENT OF THE INCIDENCE
p.(None): An assessment of whether an event is serious is usually made by the investigator's rapporteur.
p.(None): CAUSATION ASSESSMENT
p.(None): In determining whether an adverse event is a side effect, consideration is given to whether there is a viable possibility
p.(None): establishing a causal link between the event and the investigational drug based on an analysis of the available evidence.
p.(None): The assessment of whether there is a reasonable possibility of a causal relationship is usually made by the researcher.
p.(None): In the absence of information provided by the investigator-rapporteur on causality, the investigator shall consult
p.(None): with the investigating rapporteur and encourages him to express his views on the matter. Investigator
...
Health / Physically Disabled
Searching for indicator illness:
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p.(None): the designation of the clinical trial plans (s) with the study drug in BiH.
p.(None): ADVERSE REACTIONS OF MEDICINES NOT RECEIVED AS SUSAR
p.(None): In particular, there is no need for testing contractors to report as SUSAR (but may require some
p.(None): other actions as described below)
p.(None): • side effects not related to IMP but to additional drugs (non-IMP) and not resulting from interactions with IMP;
p.(None): • SUSAR in a non-sponsor clinical study;
p.(None): • adverse reactions to medicines occurring outside BiH beyond the clinical trial, exclusively used as an IMP in
p.(None): BIH.
p.(None): NOTIFICATION OF ADVERSE REACTIONS RELATED TO ADDITIONAL MEDICINES (NON-IMP)
p.(None): Safety notification regarding additional medicines is done in accordance with the Regulations on the method of reporting,
p.(None): of collecting and monitoring adverse drug reactions (Official Gazette of Bosnia and Herzegovina, No. 58/12)
p.(None): .
p.(None): OTHER IMPORTANT SAFETY INFORMATION THAT DOES NOT COVER SUSAR - OTHER MEASURES
p.(None): Events may occur during a clinical trial that do not fall within the definition of SUSAR and are therefore not subject to
p.(None): reporting requirements for SUSARs, although they may be relevant in terms of respondent safety.
p.(None): For example, new developments related to the study or development of IMP may affect security
p.(None): respondents, such as:
p.(None): - A serious adverse event that could be related to study procedures and that could modify implementation
p.(None): studies;
p.(None): - Significant risk to the population, such as lack of efficiency in the IMP used for
p.(None): treatment of a life-threatening illness;
p.(None): - A major safety breakthrough from a recently completed animal study (such as
p.(None): carcinogenicity);
p.(None): - Suspension of the study for safety reasons, if the study is conducted with the same examinee
p.(None): a medicinal product in another country by the same sponsor;
p.(None): - Recommendations of the DSMB (Data and Safety Monitoring Board), if any, where relevant to the safety of the respondents.
p.(None): These events / observations may not be reported as SUSAR, but they may require others
p.(None): actions such as:
p.(None): - Emergency security measures and their notifications;
p.(None): - Significant amendments;
p.(None): - Early interruption of testing.
p.(None): In addition to the examples above, it is recommended that the contracting authority inform the Agency and the Ethics Committees
p.(None): on any other security issues that could significantly alter the current assessment of the benefit-risk balance
p.(None): of the tested product.
p.(None): Safety information related to medicines currently under trial in BiH needs to be provided
p.(None): To the Agency, in paper form, within the shortest possible period of time.
p.(None): SUBMITTING RELEVANT INFORMATION
p.(None): The contracting authority must report any information that is 'relevant', that is, information that is
p.(None): necessary to:
p.(None): - check that the expected therapeutic and public health benefits continue to justify the foreseeable risks, and
p.(None): - Administratively processed the report.
p.(None): In identifying irrelevant and relevant information, medical and
...
Social / Threat of Stigma
Searching for indicator threat:
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p.(None): INSTRUCTIONS ON THE METHOD OF SAFETY REPORTING WITHIN THE CLINICAL TEST
p.(None): This guide defines how to collect, check, and report adverse events and adverse events
p.(None): (side effects) that occur in clinical trials.
p.(None): METHOD OF NOTIFYING TESTING ORDERS FROM RESEARCHERS ABOUT ADVERSE EVENTS AND SERIOUS ADVERSE
p.(None): EVENTS
p.(None): Adverse event is an adverse event that occurred during the period of drug administration and for which a cause-and-effect relationship with
p.(None): the use of the drug does not have to be proven. Unwanted experience is any unintended and unwanted sign
p.(None): (eg, abnormal laboratory findings), a symptom or disease, temporally associated with the administration of the drug.
p.(None): A serious adverse event1 is an adverse event that results in death, immediate life threat,
p.(None): disability, hospital treatment, extension of existing hospital treatment, congenital anomalies, or defect
p.(None): discovered at birth, or requires intervention to prevent the aforementioned consequences.
p.(None): The researcher records and records adverse events or laboratory abnormalities that are planned for the clinical setting
p.(None): tests listed as crucial to the safety assessment and shall be reported to the contracting authority
p.(None): in accordance with the notification requirements and within the time limits set by the clinical trial plan.
p.(None): The researcher records and records all adverse events unless otherwise provided by the clinical plan
p.(None): testing. The researcher informs the research client of any serious adverse events that occur
p.(None): to the respondent treated by the investigator during the clinical trial, unless otherwise provided by the plan
p.(None): clinical trial.
p.(None): The researcher informs the client without undue delay and within 24 hours of finding out about them
p.(None): trials on serious adverse events, unless, for specific adverse events, a clinical plan
p.(None): no urgent reporting was found to be necessary. If necessary, the researcher shall send to the client
p.(None): a follow up report to enable the testing contractor to determine if it is affected
p.(None): a serious adverse event on the benefit-risk relationship of the clinical trial.
p.(None): 1 These consequences must be taken into account at the time of the event. For example, in relation to a life-threatening event, it does
p.(None): refers to an event in which the respondent was at risk of death at the time of the event; it does not refer to an event that
...
Social / Youth/Minors
Searching for indicator minor:
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p.(None): - Significant amendments;
p.(None): - Early interruption of testing.
p.(None): In addition to the examples above, it is recommended that the contracting authority inform the Agency and the Ethics Committees
p.(None): on any other security issues that could significantly alter the current assessment of the benefit-risk balance
p.(None): of the tested product.
p.(None): Safety information related to medicines currently under trial in BiH needs to be provided
p.(None): To the Agency, in paper form, within the shortest possible period of time.
p.(None): SUBMITTING RELEVANT INFORMATION
p.(None): The contracting authority must report any information that is 'relevant', that is, information that is
p.(None): necessary to:
p.(None): - check that the expected therapeutic and public health benefits continue to justify the foreseeable risks, and
p.(None): - Administratively processed the report.
p.(None): In identifying irrelevant and relevant information, medical and
p.(None): scientific assessment.
p.(None): In particular, new administrative information that might affect the processing of the report should be considered
p.(None): 'relevant'. One example is information that can help identify potential duplicates.
p.(None): It may turn out, after initial reporting, that the event is not SUSAR, for example, due to a deficiency
p.(None): causation, seriousness or unexpectedness (hereinafter referred to as "downgrade"). Downgrades should be considered
p.(None): relevant information.
p.(None): Examples of irrelevant information are minor date changes or typographical error corrections
p.(None): the previous version of the report.
p.(None): INFORMATION OF THE RESEARCHER BY THE TESTING ORDER
p.(None): The investigator will also inform all investigators.
p.(None): The client of a clinical trial conducted in BiH shall report all relevant suspected information
p.(None): unexpected serious adverse reactions to the investigational drugs that occur during that clinical trial in BiH.
p.(None): The deadline for notification of suspected unexpected serious adverse reactions is set depending on
p.(None): of the severity of the side effect, and is:
p.(None): a) in the case of life-threatening or life-threatening suspicion, of unexpected serious adverse reactions occurring during that period;
p.(None): clinical trial in BiH as soon as possible and in any case not later than seven days after
p.(None): the client learns of a side effect; if necessary, ensure timely reporting, the contracting authority
p.(None): may submit an initial incomplete report followed by a full follow-up report,
p.(None): within eight days at the latest;
p.(None): b) in the case of non-lethal SUSARs or suspected unexpected serious, non-life-threatening side effects which
p.(None): occur during that clinical trial in BiH, not later than 15 days after the client becomes aware of a side effect;
p.(None): c) in case of suspected unexpected serious adverse reactions occurring during that clinical event
p.(None): interrogations in BiH, which were initially considered non-lethal and life-threatening, and for which
p.(None): they turn out to be deadly or life-threatening, as soon as possible and in any case the furthest away
p.(None): within seven days after the client learns that the side effect is deadly or dangerous
p.(None): life.
...
Social / parents
Searching for indicator parent:
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p.(None): of the unexpected serious side effects the version of the reference safety information that is
p.(None): valid at the time of the occurrence of unexpected serious adverse reactions. Therefore, changing the security reference
p.(None): the information influences the number of side effects to be reported as suspected unexpected serious side effects.
p.(None): The expectation assessment is usually done by the contracting authority. If the investigating rapporteur has provided
p.(None): expectation information, the contracting authority shall take them into account.
p.(None): METHOD OF NOTIFICATION OF THE AGENCY AND ETHICAL COMMITTEES BY THE CONTRACTING AUTHORITY ABOUT SUSPECTING Unexpected DANGEROUS
p.(None): SIDE EFFECTS
p.(None): 06.35 Suspected Unexpected Serious Adverse Reactions -SUSAR
p.(None): The client of the clinical trial conducted in BiH submits all relevant information on
p.(None): suspects the following unexpected serious side effects:
p.(None): • any suspected unexpected serious adverse reactions to the investigational drugs that occur
p.(None): during that clinical trial;
p.(None): • any suspected unexpected serious side effects associated with the same active substance, regardless of
p.(None): pharmaceutical form and strength or indication under investigation, u
p.(None): investigational drug and occurring in a clinical trial conducted (exclusively) outside BiH, if clinical
p.(None): testing commissioned by:
p.(None): - that client; or
p.(None): - different client who is part of the same parent company as the client clinical
p.(None): trials, or who jointly develops a drug with the clinical trial client3
p.(None): on the basis of a formal agreement;
p.(None): • any suspected unexpected serious side effects of the study drug that occur in any of the subjects in
p.(None): the clinical trial, to be determined or to be seen by the client at the end of the clinical trial.
p.(None): Deadline for notifying the Agency and the Ethics Committees of suspected unexpected
p.(None): The serious side effect was determined depending on the severity of the side effect and amounts to:
p.(None): a) in the case of life-threatening or life-threatening suspicion, of unexpected serious adverse reactions occurring during that period;
p.(None): clinical trial in BiH as soon as possible and in any case not later than seven days after
p.(None): the client learns of a side effect; if necessary, ensure timely reporting, the contracting authority
p.(None): may submit an initial incomplete report followed by a full follow-up report,
p.(None): within eight days at the latest;
p.(None): b) in the case of non-lethal SUSARs or suspected unexpected serious, non-life-threatening side effects which
p.(None): occur during that clinical trial in BiH, not later than 15 days after the client becomes aware of a side effect;
p.(None): c) in case of suspected unexpected serious adverse reactions occurring during that clinical trial in
p.(None): BiH, which were initially considered non-lethal and life-threatening and turned out to be deadly or
p.(None): life-threatening, as soon as possible, and in any case not later than seven days after
p.(None): the client learns that the side effect is deadly or life-threatening;
p.(None): d) in case of suspected unexpected serious adverse reactions occurring during that clinical trial outside
p.(None): BiH, even in case of suspected unexpected serious side effects related to the same active substance, regardless
p.(None): to pharmaceutical form and strength or
p.(None): 3 Obtaining the investigational drug or safety information to a prospective potential marketing authorization holder
p.(None): marketing is not considered a joint development.
p.(None): the indication being investigated, in the investigational drug, and which appear in the clinical trial being conducted
p.(None): (exclusively) outside BiH, if the clinical trial was commissioned by that client or by a different client
p.(None): of the same parent company, the client of the clinical trial is obliged to the Agency at least once every six months
p.(None): to submit a linear list of all SUSARs for the observed period, with the accompanying clinical client report
p.(None): examinations on major security issues.
p.(None): SUSAR MONITORING REPORT
p.(None): If the initial report of suspected unexpected serious adverse reactions (fatal or life-threatening) is incomplete, (at
p.(None): example: if the contracting authority did not provide all the information within seven days), the contracting authority within
p.(None): an additional eight days submit a full report based on initial information.
p.(None): The countdown for submission of the initial report (day 0 = Di 0) starts as soon as the contracting authority receives it
p.(None): information containing minimum reporting criteria.
p.(None): If the trial contractor receives significant new information on a case already recorded,
p.(None): the countdown starts again from zero, that is, when the new information is received. This information is provided in
p.(None): follow-up report within 15 days.
p.(None): If the initial report of suspected unexpected serious adverse reaction initially considered to be
p.(None): not deadly or life-threatening, but turned out to be deadly or life-threatening,
p.(None): incomplete, it should be reported as soon as possible, but within seven days of learning that the side effect is
p.(None): deadly or life-threatening. The contracting authority shall submit a completed report within an additional eight days.
p.(None): In cases where SUSAR, which was initially considered not to be life-threatening or life-threatening, turns out to be
...
General/Other / Other Country
Searching for indicator another country:
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p.(None): other actions as described below)
p.(None): • side effects not related to IMP but to additional drugs (non-IMP) and not resulting from interactions with IMP;
p.(None): • SUSAR in a non-sponsor clinical study;
p.(None): • adverse reactions to medicines occurring outside BiH beyond the clinical trial, exclusively used as an IMP in
p.(None): BIH.
p.(None): NOTIFICATION OF ADVERSE REACTIONS RELATED TO ADDITIONAL MEDICINES (NON-IMP)
p.(None): Safety notification regarding additional medicines is done in accordance with the Regulations on the method of reporting,
p.(None): of collecting and monitoring adverse drug reactions (Official Gazette of Bosnia and Herzegovina, No. 58/12)
p.(None): .
p.(None): OTHER IMPORTANT SAFETY INFORMATION THAT DOES NOT COVER SUSAR - OTHER MEASURES
p.(None): Events may occur during a clinical trial that do not fall within the definition of SUSAR and are therefore not subject to
p.(None): reporting requirements for SUSARs, although they may be relevant in terms of respondent safety.
p.(None): For example, new developments related to the study or development of IMP may affect security
p.(None): respondents, such as:
p.(None): - A serious adverse event that could be related to study procedures and that could modify implementation
p.(None): studies;
p.(None): - Significant risk to the population, such as lack of efficiency in the IMP used for
p.(None): treatment of a life-threatening illness;
p.(None): - A major safety breakthrough from a recently completed animal study (such as
p.(None): carcinogenicity);
p.(None): - Suspension of the study for safety reasons, if the study is conducted with the same examinee
p.(None): a medicinal product in another country by the same sponsor;
p.(None): - Recommendations of the DSMB (Data and Safety Monitoring Board), if any, where relevant to the safety of the respondents.
p.(None): These events / observations may not be reported as SUSAR, but they may require others
p.(None): actions such as:
p.(None): - Emergency security measures and their notifications;
p.(None): - Significant amendments;
p.(None): - Early interruption of testing.
p.(None): In addition to the examples above, it is recommended that the contracting authority inform the Agency and the Ethics Committees
p.(None): on any other security issues that could significantly alter the current assessment of the benefit-risk balance
p.(None): of the tested product.
p.(None): Safety information related to medicines currently under trial in BiH needs to be provided
p.(None): To the Agency, in paper form, within the shortest possible period of time.
p.(None): SUBMITTING RELEVANT INFORMATION
p.(None): The contracting authority must report any information that is 'relevant', that is, information that is
p.(None): necessary to:
p.(None): - check that the expected therapeutic and public health benefits continue to justify the foreseeable risks, and
p.(None): - Administratively processed the report.
p.(None): In identifying irrelevant and relevant information, medical and
p.(None): scientific assessment.
p.(None): In particular, new administrative information that might affect the processing of the report should be considered
p.(None): 'relevant'. One example is information that can help identify potential duplicates.
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.(None): clinical trials or persons who continuously perform safety assessments during the clinical trial.
p.(None): However, if for clinical trials conducted in diseases with high morbidity or high
p.(None): mortality, where the ultimate indicators of efficacy could also be the suspicion of unexpected serious side effects, or
p.(None): when the ultimate indicator of clinical trial effectiveness is death or other
p.(None): A "serious" outcome (which could potentially be reported as suspected unexpectedly serious
p.(None): side effect), systematic disclosure of the identity of the study drug could compromise the integrity of the clinical
p.(None): testing. In these and similar circumstances, the trial client points out in the clinical trial plan which ones are serious
p.(None): events should be treated as disease-related and not susceptible to systematically revealing the identity of the subject
p.(None): drug and accelerated reporting.
p.(None): If, after discovering the identity of an investigational drug for an event, it turns out to be SUSAR, the rules apply
p.(None): for reporting suspected unexpected serious side effects.
p.(None): SUSAR RELATED TO ACTIVE COMPARATOR OR PLACEBO
p.(None): Comparators and placebo are IMPs. Therefore, the same requirements for SUSARs associated with an active comparator apply
p.(None): reporting as for the IMP test. Placebo-related events do not usually meet the criteria for SUSAR
p.(None): and thus for emergency reporting. However, where SUSARs are associated with placebo (eg reaction due to ancillary
p.(None): substance or impurity), the contracting authority should report such cases.
p.(None): ANNUAL REPORTING OF SAFETY TENDERER
p.(None): With regard to the medicines tested (except for placebo), the study sponsor is obliged to submit annually
p.(None): a report to the Agency and the Ethics Committees on the safety of each study drug used in the clinical trial
p.(None): to which he is the client.
p.(None): In the case of a clinical trial involving the use of more than one study drug,
p.(None): the trial contracting authority may, if provided for in the clinical trial plan, submit one report on
p.(None): safety for all investigational drugs used in that clinical trial.
p.(None): The annual report contains only aggregate and anonymous data.
p.(None): The annual reporting obligation begins with the first approval of the clinical trial and ends with the completion of the last
p.(None): clinical trial conducted by the client with the investigational drug in BiH.
p.(None): The report in the appendix contains the security reference information in effect at the beginning of the period of which
p.(None): is being reported.
p.(None): The security reference information in effect at the beginning of the reporting period serves as a
p.(None): reference safety information during the reporting period.
...
p.(None): BIH.
p.(None): NOTIFICATION OF ADVERSE REACTIONS RELATED TO ADDITIONAL MEDICINES (NON-IMP)
p.(None): Safety notification regarding additional medicines is done in accordance with the Regulations on the method of reporting,
p.(None): of collecting and monitoring adverse drug reactions (Official Gazette of Bosnia and Herzegovina, No. 58/12)
p.(None): .
p.(None): OTHER IMPORTANT SAFETY INFORMATION THAT DOES NOT COVER SUSAR - OTHER MEASURES
p.(None): Events may occur during a clinical trial that do not fall within the definition of SUSAR and are therefore not subject to
p.(None): reporting requirements for SUSARs, although they may be relevant in terms of respondent safety.
p.(None): For example, new developments related to the study or development of IMP may affect security
p.(None): respondents, such as:
p.(None): - A serious adverse event that could be related to study procedures and that could modify implementation
p.(None): studies;
p.(None): - Significant risk to the population, such as lack of efficiency in the IMP used for
p.(None): treatment of a life-threatening illness;
p.(None): - A major safety breakthrough from a recently completed animal study (such as
p.(None): carcinogenicity);
p.(None): - Suspension of the study for safety reasons, if the study is conducted with the same examinee
p.(None): a medicinal product in another country by the same sponsor;
p.(None): - Recommendations of the DSMB (Data and Safety Monitoring Board), if any, where relevant to the safety of the respondents.
p.(None): These events / observations may not be reported as SUSAR, but they may require others
p.(None): actions such as:
p.(None): - Emergency security measures and their notifications;
p.(None): - Significant amendments;
p.(None): - Early interruption of testing.
p.(None): In addition to the examples above, it is recommended that the contracting authority inform the Agency and the Ethics Committees
p.(None): on any other security issues that could significantly alter the current assessment of the benefit-risk balance
p.(None): of the tested product.
p.(None): Safety information related to medicines currently under trial in BiH needs to be provided
p.(None): To the Agency, in paper form, within the shortest possible period of time.
p.(None): SUBMITTING RELEVANT INFORMATION
p.(None): The contracting authority must report any information that is 'relevant', that is, information that is
p.(None): necessary to:
p.(None): - check that the expected therapeutic and public health benefits continue to justify the foreseeable risks, and
p.(None): - Administratively processed the report.
p.(None): In identifying irrelevant and relevant information, medical and
p.(None): scientific assessment.
p.(None): In particular, new administrative information that might affect the processing of the report should be considered
p.(None): 'relevant'. One example is information that can help identify potential duplicates.
p.(None): It may turn out, after initial reporting, that the event is not SUSAR, for example, due to a deficiency
p.(None): causation, seriousness or unexpectedness (hereinafter referred to as "downgrade"). Downgrades should be considered
p.(None): relevant information.
p.(None): Examples of irrelevant information are minor date changes or typographical error corrections
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.(None): INSTRUCTIONS ON THE METHOD OF SAFETY REPORTING WITHIN THE CLINICAL TEST
p.(None): This guide defines how to collect, check, and report adverse events and adverse events
p.(None): (side effects) that occur in clinical trials.
p.(None): METHOD OF NOTIFYING TESTING ORDERS FROM RESEARCHERS ABOUT ADVERSE EVENTS AND SERIOUS ADVERSE
p.(None): EVENTS
p.(None): Adverse event is an adverse event that occurred during the period of drug administration and for which a cause-and-effect relationship with
p.(None): the use of the drug does not have to be proven. Unwanted experience is any unintended and unwanted sign
p.(None): (eg, abnormal laboratory findings), a symptom or disease, temporally associated with the administration of the drug.
p.(None): A serious adverse event1 is an adverse event that results in death, immediate life threat,
p.(None): disability, hospital treatment, extension of existing hospital treatment, congenital anomalies, or defect
p.(None): discovered at birth, or requires intervention to prevent the aforementioned consequences.
p.(None): The researcher records and records adverse events or laboratory abnormalities that are planned for the clinical setting
p.(None): tests listed as crucial to the safety assessment and shall be reported to the contracting authority
p.(None): in accordance with the notification requirements and within the time limits set by the clinical trial plan.
p.(None): The researcher records and records all adverse events unless otherwise provided by the clinical plan
p.(None): testing. The researcher informs the research client of any serious adverse events that occur
p.(None): to the respondent treated by the investigator during the clinical trial, unless otherwise provided by the plan
p.(None): clinical trial.
p.(None): The researcher informs the client without undue delay and within 24 hours of finding out about them
p.(None): trials on serious adverse events, unless, for specific adverse events, a clinical plan
p.(None): no urgent reporting was found to be necessary. If necessary, the researcher shall send to the client
p.(None): a follow up report to enable the testing contractor to determine if it is affected
p.(None): a serious adverse event on the benefit-risk relationship of the clinical trial.
p.(None): 1 These consequences must be taken into account at the time of the event. For example, in relation to a life-threatening event, it does
p.(None): refers to an event in which the respondent was at risk of death at the time of the event; it does not refer to an event that
p.(None): it can hypothetically cause death if it is more severe.
p.(None): In cases where reporting is not required immediately, the investigator shall submit the report as appropriate
p.(None): of the timeframe, taking into account the specifics of the trial and the severity of the adverse event, according to
p.(None): the deadlines set out in the protocol or booklet for researchers.
p.(None): After completing the clinical trial, the researcher should not actively monitor the subjects he / she treated at
...
p.(None): weight2 or outcome are not known or described in the Summary of Product Characteristics or in the Research Leaflet for
p.(None): drugs that are in clinical trials and cannot be expected based on known pharmacological properties of the drug.
p.(None): It is the responsibility of the test client to ensure that all reported adverse events are cumulative,
p.(None): - have a reasonable possibility of causation with the product under test (IMP)
p.(None): - are "serious" and
p.(None): - are "unexpected".
p.(None): 2 The term “weight” is used here to describe the intensity of a particular event. This should be different from the term
p.(None): "Serious."
p.(None): ASSESSMENT OF THE INCIDENCE
p.(None): An assessment of whether an event is serious is usually made by the investigator's rapporteur.
p.(None): CAUSATION ASSESSMENT
p.(None): In determining whether an adverse event is a side effect, consideration is given to whether there is a viable possibility
p.(None): establishing a causal link between the event and the investigational drug based on an analysis of the available evidence.
p.(None): The assessment of whether there is a reasonable possibility of a causal relationship is usually made by the researcher.
p.(None): In the absence of information provided by the investigator-rapporteur on causality, the investigator shall consult
p.(None): with the investigating rapporteur and encourages him to express his views on the matter. Investigator
p.(None): does not diminish the value of the causality assessment given by the researcher. If the contracting authority does not agree with
p.(None): the investigator's causality assessment reports the unexpected serious side effects of both.
p.(None): ASSESSMENT / EXPECTATION ASSESSMENT
p.(None): When determining whether an adverse event is unexpected, it considers whether the event adds significant information about
p.(None): specificity, increase in frequency or severity of a known serious adverse reaction that has already been documented.
p.(None): The expectation of adverse effects is determined by the client of the test in the reference safety information.
p.(None): Expectancy is determined on the basis of previously observed events with the active substance and not on the basis of expected events
p.(None): pharmacological properties of the drug or events related to the respondent's disease.
p.(None): The safety reference information provided in the Product Features Summary (SmPC) or brochure for
p.(None): researchers (IB). A cover letter indicates where the reference safety information is located
p.(None): within the documentation regarding the request. Investigator of the test as a reference security
p.(None): the information selects the summary of product characteristics that is most appropriate for safety
p.(None): respondents.
p.(None): Reference safety information may change during the conduct of a clinical trial. For reporting purposes
p.(None): of the unexpected serious side effects the version of the reference safety information that is
p.(None): valid at the time of the occurrence of unexpected serious adverse reactions. Therefore, changing the security reference
p.(None): the information influences the number of side effects to be reported as suspected unexpected serious side effects.
p.(None): The expectation assessment is usually done by the contracting authority. If the investigating rapporteur has provided
p.(None): expectation information, the contracting authority shall take them into account.
p.(None): METHOD OF NOTIFICATION OF THE AGENCY AND ETHICAL COMMITTEES BY THE CONTRACTING AUTHORITY ABOUT SUSPECTING Unexpected DANGEROUS
p.(None): SIDE EFFECTS
p.(None): 06.35 Suspected Unexpected Serious Adverse Reactions -SUSAR
p.(None): The client of the clinical trial conducted in BiH submits all relevant information on
p.(None): suspects the following unexpected serious side effects:
p.(None): • any suspected unexpected serious adverse reactions to the investigational drugs that occur
p.(None): during that clinical trial;
p.(None): • any suspected unexpected serious side effects associated with the same active substance, regardless of
p.(None): pharmaceutical form and strength or indication under investigation, u
p.(None): investigational drug and occurring in a clinical trial conducted (exclusively) outside BiH, if clinical
p.(None): testing commissioned by:
p.(None): - that client; or
p.(None): - different client who is part of the same parent company as the client clinical
p.(None): trials, or who jointly develops a drug with the clinical trial client3
p.(None): on the basis of a formal agreement;
p.(None): • any suspected unexpected serious side effects of the study drug that occur in any of the subjects in
p.(None): the clinical trial, to be determined or to be seen by the client at the end of the clinical trial.
p.(None): Deadline for notifying the Agency and the Ethics Committees of suspected unexpected
p.(None): The serious side effect was determined depending on the severity of the side effect and amounts to:
p.(None): a) in the case of life-threatening or life-threatening suspicion, of unexpected serious adverse reactions occurring during that period;
p.(None): clinical trial in BiH as soon as possible and in any case not later than seven days after
p.(None): the client learns of a side effect; if necessary, ensure timely reporting, the contracting authority
p.(None): may submit an initial incomplete report followed by a full follow-up report,
p.(None): within eight days at the latest;
p.(None): b) in the case of non-lethal SUSARs or suspected unexpected serious, non-life-threatening side effects which
p.(None): occur during that clinical trial in BiH, not later than 15 days after the client becomes aware of a side effect;
p.(None): c) in case of suspected unexpected serious adverse reactions occurring during that clinical trial in
p.(None): BiH, which were initially considered non-lethal and life-threatening and turned out to be deadly or
p.(None): life-threatening, as soon as possible, and in any case not later than seven days after
p.(None): the client learns that the side effect is deadly or life-threatening;
p.(None): d) in case of suspected unexpected serious adverse reactions occurring during that clinical trial outside
p.(None): BiH, even in case of suspected unexpected serious side effects related to the same active substance, regardless
p.(None): to pharmaceutical form and strength or
p.(None): 3 Obtaining the investigational drug or safety information to a prospective potential marketing authorization holder
p.(None): marketing is not considered a joint development.
p.(None): the indication being investigated, in the investigational drug, and which appear in the clinical trial being conducted
p.(None): (exclusively) outside BiH, if the clinical trial was commissioned by that client or by a different client
p.(None): of the same parent company, the client of the clinical trial is obliged to the Agency at least once every six months
p.(None): to submit a linear list of all SUSARs for the observed period, with the accompanying clinical client report
p.(None): examinations on major security issues.
p.(None): SUSAR MONITORING REPORT
p.(None): If the initial report of suspected unexpected serious adverse reactions (fatal or life-threatening) is incomplete, (at
p.(None): example: if the contracting authority did not provide all the information within seven days), the contracting authority within
p.(None): an additional eight days submit a full report based on initial information.
p.(None): The countdown for submission of the initial report (day 0 = Di 0) starts as soon as the contracting authority receives it
p.(None): information containing minimum reporting criteria.
p.(None): If the trial contractor receives significant new information on a case already recorded,
p.(None): the countdown starts again from zero, that is, when the new information is received. This information is provided in
p.(None): follow-up report within 15 days.
p.(None): If the initial report of suspected unexpected serious adverse reaction initially considered to be
p.(None): not deadly or life-threatening, but turned out to be deadly or life-threatening,
p.(None): incomplete, it should be reported as soon as possible, but within seven days of learning that the side effect is
p.(None): deadly or life-threatening. The contracting authority shall submit a completed report within an additional eight days.
p.(None): In cases where SUSAR, which was initially considered not to be life-threatening or life-threatening, turns out to be
p.(None): lethal or life-threatening, a joint report shall be drawn up if the initial report has not yet been submitted.
p.(None): DETERMINING THE IDENTITY OF THE ALLOCATED TREATMENT
p.(None): The researcher discovers the identity of the assigned treatment of the subjects while conducting the clinical
p.(None): examinations only if identity disclosure is relevant to the respondent's safety.
p.(None): When reporting to the Agency and the Ethics Committees on SUSAR, the client reveals the identity of the treatment
p.(None): assigned to the respondents to whom SUSAR refers.
p.(None): If there is a possible suspicion of an unexpected serious side effect, only the contracting authority shall disclose
p.(None): identity only for that respondent. The drug still remains masked to other persons responsible for
p.(None): continuous conduct of clinical trials (such as administration, monitors,
p.(None): researchers) and those persons responsible for analyzing the data and interpreting the results after completion
p.(None): clinical trial, such as biometric personnel.
p.(None): The information disclosed is available only to those persons who are required to participate in the security reporting to the
p.(None): clinical trials or persons who continuously perform safety assessments during the clinical trial.
p.(None): However, if for clinical trials conducted in diseases with high morbidity or high
p.(None): mortality, where the ultimate indicators of efficacy could also be the suspicion of unexpected serious side effects, or
p.(None): when the ultimate indicator of clinical trial effectiveness is death or other
p.(None): A "serious" outcome (which could potentially be reported as suspected unexpectedly serious
p.(None): side effect), systematic disclosure of the identity of the study drug could compromise the integrity of the clinical
p.(None): testing. In these and similar circumstances, the trial client points out in the clinical trial plan which ones are serious
p.(None): events should be treated as disease-related and not susceptible to systematically revealing the identity of the subject
p.(None): drug and accelerated reporting.
p.(None): If, after discovering the identity of an investigational drug for an event, it turns out to be SUSAR, the rules apply
p.(None): for reporting suspected unexpected serious side effects.
p.(None): SUSAR RELATED TO ACTIVE COMPARATOR OR PLACEBO
p.(None): Comparators and placebo are IMPs. Therefore, the same requirements for SUSARs associated with an active comparator apply
p.(None): reporting as for the IMP test. Placebo-related events do not usually meet the criteria for SUSAR
p.(None): and thus for emergency reporting. However, where SUSARs are associated with placebo (eg reaction due to ancillary
p.(None): substance or impurity), the contracting authority should report such cases.
p.(None): ANNUAL REPORTING OF SAFETY TENDERER
p.(None): With regard to the medicines tested (except for placebo), the study sponsor is obliged to submit annually
p.(None): a report to the Agency and the Ethics Committees on the safety of each study drug used in the clinical trial
p.(None): to which he is the client.
p.(None): In the case of a clinical trial involving the use of more than one study drug,
p.(None): the trial contracting authority may, if provided for in the clinical trial plan, submit one report on
p.(None): safety for all investigational drugs used in that clinical trial.
p.(None): The annual report contains only aggregate and anonymous data.
p.(None): The annual reporting obligation begins with the first approval of the clinical trial and ends with the completion of the last
p.(None): clinical trial conducted by the client with the investigational drug in BiH.
p.(None): The report in the appendix contains the security reference information in effect at the beginning of the period of which
p.(None): is being reported.
p.(None): The security reference information in effect at the beginning of the reporting period serves as a
p.(None): reference safety information during the reporting period.
p.(None): If the reference security information changes significantly during the reporting period, then
p.(None): the changes are stated in the annual safety report. Moreover, in this case the security reference is revised
p.(None): the information is submitted in addition to the report, with the security reference information in force at
p.(None): the beginning of the reporting period. Despite the change in the reference security information, the reference
p.(None): security information in place at the beginning of the reporting period serves as a reference
p.(None): security information during the reporting period.
p.(None): Details on annual security reporting, including rules on identity disclosure,
p.(None): it is prescribed in the ICH E2F - Development Safety Update Report 'DSUR' guidelines.
p.(None): POSTMARKETING CLINICAL STUDIES SAFETY NOTIFICATION
p.(None): Safety notification from post-marketing clinical studies is done in accordance with the Rules of Procedure
...
p.(None): .
p.(None): OTHER IMPORTANT SAFETY INFORMATION THAT DOES NOT COVER SUSAR - OTHER MEASURES
p.(None): Events may occur during a clinical trial that do not fall within the definition of SUSAR and are therefore not subject to
p.(None): reporting requirements for SUSARs, although they may be relevant in terms of respondent safety.
p.(None): For example, new developments related to the study or development of IMP may affect security
p.(None): respondents, such as:
p.(None): - A serious adverse event that could be related to study procedures and that could modify implementation
p.(None): studies;
p.(None): - Significant risk to the population, such as lack of efficiency in the IMP used for
p.(None): treatment of a life-threatening illness;
p.(None): - A major safety breakthrough from a recently completed animal study (such as
p.(None): carcinogenicity);
p.(None): - Suspension of the study for safety reasons, if the study is conducted with the same examinee
p.(None): a medicinal product in another country by the same sponsor;
p.(None): - Recommendations of the DSMB (Data and Safety Monitoring Board), if any, where relevant to the safety of the respondents.
p.(None): These events / observations may not be reported as SUSAR, but they may require others
p.(None): actions such as:
p.(None): - Emergency security measures and their notifications;
p.(None): - Significant amendments;
p.(None): - Early interruption of testing.
p.(None): In addition to the examples above, it is recommended that the contracting authority inform the Agency and the Ethics Committees
p.(None): on any other security issues that could significantly alter the current assessment of the benefit-risk balance
p.(None): of the tested product.
p.(None): Safety information related to medicines currently under trial in BiH needs to be provided
p.(None): To the Agency, in paper form, within the shortest possible period of time.
p.(None): SUBMITTING RELEVANT INFORMATION
p.(None): The contracting authority must report any information that is 'relevant', that is, information that is
p.(None): necessary to:
p.(None): - check that the expected therapeutic and public health benefits continue to justify the foreseeable risks, and
p.(None): - Administratively processed the report.
p.(None): In identifying irrelevant and relevant information, medical and
p.(None): scientific assessment.
p.(None): In particular, new administrative information that might affect the processing of the report should be considered
p.(None): 'relevant'. One example is information that can help identify potential duplicates.
p.(None): It may turn out, after initial reporting, that the event is not SUSAR, for example, due to a deficiency
p.(None): causation, seriousness or unexpectedness (hereinafter referred to as "downgrade"). Downgrades should be considered
p.(None): relevant information.
p.(None): Examples of irrelevant information are minor date changes or typographical error corrections
p.(None): the previous version of the report.
p.(None): INFORMATION OF THE RESEARCHER BY THE TESTING ORDER
p.(None): The investigator will also inform all investigators.
p.(None): The client of a clinical trial conducted in BiH shall report all relevant suspected information
p.(None): unexpected serious adverse reactions to the investigational drugs that occur during that clinical trial in BiH.
p.(None): The deadline for notification of suspected unexpected serious adverse reactions is set depending on
p.(None): of the severity of the side effect, and is:
p.(None): a) in the case of life-threatening or life-threatening suspicion, of unexpected serious adverse reactions occurring during that period;
p.(None): clinical trial in BiH as soon as possible and in any case not later than seven days after
p.(None): the client learns of a side effect; if necessary, ensure timely reporting, the contracting authority
p.(None): may submit an initial incomplete report followed by a full follow-up report,
p.(None): within eight days at the latest;
p.(None): b) in the case of non-lethal SUSARs or suspected unexpected serious, non-life-threatening side effects which
p.(None): occur during that clinical trial in BiH, not later than 15 days after the client becomes aware of a side effect;
p.(None): c) in case of suspected unexpected serious adverse reactions occurring during that clinical event
p.(None): interrogations in BiH, which were initially considered non-lethal and life-threatening, and for which
p.(None): they turn out to be deadly or life-threatening, as soon as possible and in any case the furthest away
p.(None): within seven days after the client learns that the side effect is deadly or dangerous
p.(None): life.
p.(None): The information should be concise and practical. Therefore, whenever possible, information on SUSARs should be consolidated
p.(None): in the form of a linear list of SUSARs over periods determined by the nature of the research project / clinical development project and
p.(None): volume of SUSARs generated. The linear list should be accompanied by a concise review of the development security profile
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.(None): continuous conduct of clinical trials (such as administration, monitors,
p.(None): researchers) and those persons responsible for analyzing the data and interpreting the results after completion
p.(None): clinical trial, such as biometric personnel.
p.(None): The information disclosed is available only to those persons who are required to participate in the security reporting to the
p.(None): clinical trials or persons who continuously perform safety assessments during the clinical trial.
p.(None): However, if for clinical trials conducted in diseases with high morbidity or high
p.(None): mortality, where the ultimate indicators of efficacy could also be the suspicion of unexpected serious side effects, or
p.(None): when the ultimate indicator of clinical trial effectiveness is death or other
p.(None): A "serious" outcome (which could potentially be reported as suspected unexpectedly serious
p.(None): side effect), systematic disclosure of the identity of the study drug could compromise the integrity of the clinical
p.(None): testing. In these and similar circumstances, the trial client points out in the clinical trial plan which ones are serious
p.(None): events should be treated as disease-related and not susceptible to systematically revealing the identity of the subject
p.(None): drug and accelerated reporting.
p.(None): If, after discovering the identity of an investigational drug for an event, it turns out to be SUSAR, the rules apply
p.(None): for reporting suspected unexpected serious side effects.
p.(None): SUSAR RELATED TO ACTIVE COMPARATOR OR PLACEBO
p.(None): Comparators and placebo are IMPs. Therefore, the same requirements for SUSARs associated with an active comparator apply
p.(None): reporting as for the IMP test. Placebo-related events do not usually meet the criteria for SUSAR
p.(None): and thus for emergency reporting. However, where SUSARs are associated with placebo (eg reaction due to ancillary
p.(None): substance or impurity), the contracting authority should report such cases.
p.(None): ANNUAL REPORTING OF SAFETY TENDERER
p.(None): With regard to the medicines tested (except for placebo), the study sponsor is obliged to submit annually
p.(None): a report to the Agency and the Ethics Committees on the safety of each study drug used in the clinical trial
p.(None): to which he is the client.
p.(None): In the case of a clinical trial involving the use of more than one study drug,
p.(None): the trial contracting authority may, if provided for in the clinical trial plan, submit one report on
p.(None): safety for all investigational drugs used in that clinical trial.
p.(None): The annual report contains only aggregate and anonymous data.
p.(None): The annual reporting obligation begins with the first approval of the clinical trial and ends with the completion of the last
p.(None): clinical trial conducted by the client with the investigational drug in BiH.
p.(None): The report in the appendix contains the security reference information in effect at the beginning of the period of which
p.(None): is being reported.
p.(None): The security reference information in effect at the beginning of the reporting period serves as a
p.(None): reference safety information during the reporting period.
p.(None): If the reference security information changes significantly during the reporting period, then
p.(None): the changes are stated in the annual safety report. Moreover, in this case the security reference is revised
p.(None): the information is submitted in addition to the report, with the security reference information in force at
p.(None): the beginning of the reporting period. Despite the change in the reference security information, the reference
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| another country | Other Country |
| authority | Relationship to Authority |
| disability | Mentally Disabled |
| drug | Drug Usage |
| emergency | Public Emergency |
| illness | Physically Disabled |
| minor | Youth/Minors |
| parent | parents |
| placebo | participants in a control group |
| substance | Drug Usage |
| threat | Threat of Stigma |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['substance'] |
| substance | ['drug'] |
Trigger Words
ethics
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input