0A4F4F9BD490A749D5437F821CF06DF1
Manual of Adverse Event Notification and Safety Monitoring in Clinical Trials Involving Medical Devices (2016)
http://portal.anvisa.gov.br/documents/33912/2785629/MANUAL+PARA+NOTIFICA%C3%87%C3%83O+DE+EVENTOS+ADVERSOS+E+MONITORAMENTO+DE+SEGURAN%C3%87A+EM+ENSAIOS+CL%C3%8DNICOS+ENVOLVENDO+DISPOSITIVOS+M%C3%89DICOS+EM+INVESTIGA%C3%87%C3%83O/df22b9ac-688d-4e6a-8207-faf862a05994
http://leaux.net/URLS/ConvertAPI Text Files/A9810909D2FC43AD0A2194C46FEC3612.en.txt
Examining the file media/Synopses/A9810909D2FC43AD0A2194C46FEC3612.html:
This file was generated: 2020-07-15 04:07:48
| 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.000012: 12
p.000012: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000012: RESEARCH DOCTORS
p.000012: 12. BIBLIOGRAPHIC REFERENCES
p.000012: 1. ACKER JE 3rd, Pancioli AM, Crocco TJ, et al. Implementation strategies for emergency medical services
p.000012: within stroke systems of care: a policy statement from the American Heart Association / American Stroke
p.000012: Association Expert Panel on Emergency Medical Services Systems and the Stroke Council. Stroke 2007; 38: 3097–3115.
p.000012: 2. BASTOS, Alessandra Soler et al. Time of arrival of the patient with acute myocardial infarction in a
p.000012: emergency. Rev Bras Cir Cardiovasc, São José do Rio Preto, v. 27, n. 3, Sept. 2012. Available at:
p.000012: accessed on: 19 ago. 2014
p.000012: http://dx.doi.org/10.5935/1678- 9741.20120070.
p.000012: 3. International Organization for Standardization - ISO 14155: 2011 Clinical investigation of medical
p.000012: devices for human subjects - Good clinical practice available at <
p.000012: http://www.iso.org/iso/catalogue_detail?csnumber=45557>
p.000012: 4. MINISTRY OF HEALTH, WORLD HEALTH ORGANIZATION. Operational Guidelines for Establishment and Operation
p.000012: of Data and Security Monitoring Committees. Series A. Standards and Technical Manuals. Available in:
p.000012: Accessed on June 3. 2014.
p.000012: 5. THE UPPSALA MONITORING CENTER. WHO Collaborating Center for International Drug Monitoring. Glossary of Terms in
p.000012: Pharmacovigilance. Available at: . Accessed on Jun. 3 2014.
p.000013: 13
p.000013: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000013: RESEARCH DOCTORS
p.000013: 6. THE UPPSALA MONITORING CENTER. WHO Collaborating Center for International Drug Monitoring. WHO-UMC Causality
p.000013: Assessment. Available in:
p.000013: . Accessed on Jun. 3 2014.
p.000014: 14
p.000014: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000014: RESEARCH DOCTORS
p.000014: 13. PROCESS FLOWCHART
p.000014: ➢ ADVERSE EVENTS NOTIFICATION FLOWCHART IN CLINICAL TRIALS
p.000015: 15
p.000015: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000015: RESEARCH DOCTORS
p.000015: 14. FLOW CHART TO PROVIDE GUIDELINES TO CATEGORIZE ADVERSE EVENTS AND DISABILITIES OF THE
p.000015: DEVICE*. * such guidelines are not intended to show the interrelation of categories
p.000015: ADVERSE EVENT
p.000015: Does it meet the severity criteria?
p.000015: No
p.000015: Is it related to the device / procedure?
p.000015: No
p.000015: ADVERSE EVENT (EA)
p.000015: Yes
p.000015: Yes
p.000015: Serious Adverse Event (EAG)
p.000015: Adverse Device Effect (EAD)
p.000015: Is it related to the device / procedure?
p.000015: Yes
p.000015: Severe Adverse Effect of the Device (EAGD)
p.000015: IS
p.000015: expected?
p.000015: No
p.000015: Serious Unexpected Adverse Effect of the Device (EAIGD)
p.000016: 16
p.000016: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000016: RESEARCH DOCTORS
p.000016: 15. ANNEXES
p.000016: 15. 1 WHO-UMC SYSTEM FOR STANDARDIZED CAUSALITY ASSESSMENT
p.000016: 15.1.1 Table 1. Advances and limitations of the system for standardized causality assessment
p.000016: What can causality assessment do?
p.000016: What can't the causality assessment do?
p.000016: Decrease disagreement between evaluators Provide accurate quantitative measure of
p.000016: probability relationship
p.000016: Classify probability relation Distinguish between valid and invalid cases
...
Health / Mentally Disabled
Searching for indicator disability:
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p.000005: Adverse Event (EA)
p.000005: Any unfavorable medical event, unintentional injury, injury or undesirable clinical signs
p.000005: (including an abnormal laboratory finding) in research participants, users, or others,
p.000005: related or not to the medical device under investigation.
p.000005: NOTE 1: includes events related to the research device or comparator.
p.000005: NOTE 2: includes events related to the procedures involved (any procedure in the investigation protocol
p.000005: clinic).
p.000005: Medical Device Deficiencies
p.000005: The deficiency or inadequacy of a medical device related to its identity, quality,
p.000005: durability, reliability, safety or performance, such as malfunction, misuse or
p.000005: improper use and labeling.
p.000005: Medical device under investigation - medical device under test, object of the DICD, to be used in the test
p.000005: for the purpose of obtaining information for your registration or post-registration.
p.000006: 6
p.000006: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000006: RESEARCH DOCTORS
p.000006: NOTE: includes medical devices already on the market that are being evaluated for new uses
p.000006: new populations, new materials or design changes.
p.000006: Serious Adverse Event (EAG)
p.000006: One that results in any adverse experience with medical devices, occurring in and that results in
p.000006: any of the following outcomes:
p.000006: a) death;
p.000006: b) potentially fatal adverse event (one that, in the opinion of the notifier, places the individual under
p.000006: immediate risk of death due to the adverse event that occurred);
p.000006: c) persistent or significant disability / disability;
p.000006: d) requires hospitalization of the patient or prolongs hospitalization;
p.000006: e) congenital anomaly or birth defect;
p.000006: f) any suspicion of transmission of an infectious agent by means of a medical device;
p.000006: g) clinically significant event.
p.000006: NOTE 1: includes device deficiencies that could have led to a serious adverse event, if a) measures
p.000006: appropriate measures had not been taken or b) the intervention had not been carried out or c) if the circumstances
p.000006: had been less favorable. These are addressed within the scope of the event communication system
p.000006: serious adverse events.
p.000006: NOTE 2: Hospitalization planned for a pre-existing condition, or a procedure required by the
p.000006: Clinical Investigation Plan, without a serious deterioration of health, is not considered an adverse event
p.000006: serious.
p.000006: Severe Adverse Effect of the Device (EAGD)
p.000006: Adverse effect related to the device that resulted in any of the characteristic consequences of
p.000006: a serious adverse event.
p.000007: 7
p.000007: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000007: RESEARCH DOCTORS
p.000007: Serious Unexpected Adverse Effect of the Device (EAIGD)
p.000007: Serious adverse effect of the device that, by its nature, incidence, severity or consequences has not been identified
p.000007: in the most current version of the risk analysis report.
p.000007: NOTE: “expected or anticipated” is characterized as an effect that, by its nature, incidence, severity or
p.000007: consequences was previously identified in the risk analysis report.
p.000007: 4. LEGAL BASIS
p.000007: Anvisa Resolution - RDC nº 10, of February 20, 2015, which provides for regulation for the realization of
...
Health / Physically Disabled
Searching for indicator illness:
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p.000015: No
p.000015: ADVERSE EVENT (EA)
p.000015: Yes
p.000015: Yes
p.000015: Serious Adverse Event (EAG)
p.000015: Adverse Device Effect (EAD)
p.000015: Is it related to the device / procedure?
p.000015: Yes
p.000015: Severe Adverse Effect of the Device (EAGD)
p.000015: IS
p.000015: expected?
p.000015: No
p.000015: Serious Unexpected Adverse Effect of the Device (EAIGD)
p.000016: 16
p.000016: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000016: RESEARCH DOCTORS
p.000016: 15. ANNEXES
p.000016: 15. 1 WHO-UMC SYSTEM FOR STANDARDIZED CAUSALITY ASSESSMENT
p.000016: 15.1.1 Table 1. Advances and limitations of the system for standardized causality assessment
p.000016: What can causality assessment do?
p.000016: What can't the causality assessment do?
p.000016: Decrease disagreement between evaluators Provide accurate quantitative measure of
p.000016: probability relationship
p.000016: Classify probability relation Distinguish between valid and invalid cases
p.000016: Mark reports individually To prove the relationship between the intervention and the
p.000016: event
p.000016: Improve scientific, educational assessment
p.000016: Quantify the contribution of the intervention to the development of an adverse event
p.000016: Changing uncertainties to certainties
p.000017: 17
p.000017: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000017: RESEARCH DOCTORS
p.000017: 15.1.2 Box 2. WHO-UMC Causal categories
p.000017: Categories + Criteria in the assessment of causality ++
p.000017: • Event or alteration (abnormal) in laboratory examination with a plausible temporal relationship in relation to the administration of
p.000017: intervention;
p.000017: • Cannot be explained by illness or other intervention, medication;
p.000017: Right / Defined
p.000017: Likely
p.000017: Possible
p.000017: Unlikely
p.000017: Conditional / Unclassified
p.000017: • Response to plausible interruption or withdrawal (pharmacologically, pathologically);
p.000017: • Pharmacologically or phenomenologically defined event (i.e. an objective and specific disorder or phenomenon
p.000017: pharmacologically recognized);
p.000017: • Satisfactory restocking, if necessary.
p.000017: • Event or alteration (abnormal) in laboratory examination with reasonable temporal relation to the administration of
p.000017: intervention;
p.000017: • Unlikely to be attributed to a disease or other intervention, medication;
p.000017: • Response to clinically reasonable interruption or withdrawal;
p.000017: • Reexposure not required.
p.000017: • Event or alteration (abnormal) in laboratory examination with reasonable temporal relation to the administration of
p.000017: intervention;
p.000017: • It can also be explained by illness or other interventions, drugs;
p.000017: • Information about withdrawing or stopping treatment may be missing or unclear.
p.000017: • Event or alteration (abnormal) in laboratory examination that in relation to the moment of administration of the intervention makes a
p.000017: unlikely (but not impossible) relationship;
p.000017: • Illness or other treatments support plausible explanations.
p.000017: • Event or alteration (abnormal) in laboratory examination;
p.000017: • More data is needed for an appropriate assessment, or;
p.000017: • Additional data under investigation.
p.000017: Inaccessible / Unclassifiable
p.000017: • The narrative of the report suggests an adverse reaction;
p.000017: • It cannot be classified because the information is insufficient or contradictory;
p.000017: • Data cannot be supplemented or
p.000017: checked.
p.000018: 18
p.000018: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000018: RESEARCH DOCTORS
p.000018: 16. CHANGE HISTORY
p.000018: Version
p.000018: Changes made
p.000018: Explanation and Justification
p.000018: 1st edition
p.000018: Initial release
...
Social / Access to Social Goods
Searching for indicator access:
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p.000008: b) Other methods can be used for categorization provided that correspondence with the system is proven
p.000008: WHO-UMC;
p.000008: c) Suspected Unexpected Serious Adverse Reaction (SUSAR) is included in the criteria for
p.000008: notification of a serious adverse event and must be notified, however, the criteria listed in the DRC are not limited to
p.000008: he.
p.000008: d) Notifications must be made exclusively through the electronic form
p.000008: “Notification of EAGs in Clinical Trials with Medical Devices - NotivisaEC-DISPOSITIVOS”,
p.000008: available at the link: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=28308:
p.000008: ➢ Some pages of the form may take a long time to load, please wait;
p.000008: ➢ It is not necessary to log in to notify adverse events;
p.000008: ➢ After completing the last page, a protocol number and a mirror of the
p.000008: notification. Keep this number to update your notification;
p.000009: 9
p.000009: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000009: RESEARCH DOCTORS
p.000009: ➢ If the system is temporarily unavailable, notification must be sent as soon as the system
p.000009: turn back;
p.000009: ➢ In case of any difficulty or doubt, whether in relation to the correct way of filling in the data of the
p.000009: notification or information technology issue, contact Anvisa through the
p.000009: official communication. Specify that the questioning refers to “notification of adverse events in trials
p.000009: with medical devices ”or enter this information in the application data.
p.000009: 8. TRACEABILITY
p.000009: All updates regarding the evolution and other data must be made in the initial notification, changing the field
p.000009: side dish.
p.000009: ➢ To access the EA notification, access the link: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=2
p.008308: 8308
p.000010: 10
p.000010: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000010: RESEARCH DOCTORS
p.000010: ➢ Enter the notification protocol to retrieve it and update the information.
p.000010: 9. SUBMISSION OF OTHER EA's (REPORTS)
p.000010: Aggregated data for all other adverse events that are not categorized as
p.000010: serious and unexpected, whose relationship with the product under investigation is not possible, probable or
p.000010: should be systematically assessed by the sponsor or the Independent Monitoring Committee of
p.000010: The data and results of this evaluation must be submitted to Anvisa in the annual reports and final report
p.000010: clinical trials.
p.000010: 10. WHEN NOT TO NOTIFY THE ADVERSE EVENT TO ANVISA
p.000010: The adverse event need not be notified to Anvisa when it occurs outside the national territory and when the
p.000010: adverse event is defined in the clinical trial protocol as a primary or secondary outcome.
p.000011: 11
p.000011: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000011: RESEARCH DOCTORS
p.000011: 11. QUALIFICATION GRADE OF QUALIFICATION FOR HEALTH CONDITIONS (WHO)
p.000011: Light
p.000011: A problem is present less than 25% of the time, with an intensity that a person can tolerate and that rarely
p.000011: happens in the last 30 days.
p.000011: Moderate
p.000011: It means that a problem that is present less than 50% of the time, with an intensity that interferes with the day-to-day
p.000011: people and that happens occasionally in the last 30 days.
p.000011: Severe
p.000011: It means that a problem that is present more than 50% of the time, with an intensity that changes
...
Social / education
Searching for indicator educational:
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p.000016: 15. ANNEXES
p.000017: 17
p.000017: 15. 1 WHO-UMC SYSTEM FOR STANDARDIZED CAUSALITY ASSESSMENT 17
p.000017: 15.1.1 Chart 1. Advances and limitations of the system for standardized assessment of causality17 15.1.2 Chart 2. WHO-UMC
p.000017: Causal categories 18
p.000017: 16. CHANGE HISTORY
p.000019: 19
p.000004: 4
p.000004: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000004: RESEARCH DOCTORS
p.000004: 1. SIGLARY
p.000004: DICD - Medical Device Clinical Investigation Dossier
p.000004: RDC - Resolution of the Collegiate Board
p.000004: EA - Adverse Event
p.000004: EAG - Serious Adverse Event
p.000004: EAD - Adverse Effect of the Device
p.000004: EAGD - Serious Adverse Effect of the Device
p.000004: EAIGD - Serious Unexpected Adverse Effect of the Device
p.000004: EC - Clinical Trial
p.000004: WHO - World Health Organization
p.000004: RDC - Resolution of the Collegiate Board
p.000004: SUSAR - Suspected Unexpected Serious Adverse Reaction
p.000004: WHO - World Health Organization
p.000004: WHOART - The WHO Adverse Reactions Terminology
p.000004: WHO-UMC - The WHO Uppsala Monitoring Center
p.000004: 2. INTRODUCTION
p.000004: The publication of the regulation on Clinical Trials with Medical Devices in Brazil brings the notification of
p.000004: adverse events as one of the forms of security monitoring that the sponsor must perform
p.000004: during the development of the Medical Device. This manual is intended to provide
p.000004: guidelines for the Sponsor, Independent Data Monitoring Committee, Investigator
p.000004: or Legal Representatives, when applicable, do security monitoring and notification of
p.000004: adverse events in clinical trials appropriately.
p.000004: This is a non-binding regulatory measure adopted as a complement to legislation
p.000004: health, with the educational purpose of providing guidance on routines and procedures for compliance
p.000004: legislation, not intended to expand or restrict technical or administrative requirements
p.000004: settled down.
p.000005: 5
p.000005: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000005: RESEARCH DOCTORS
p.000005: 3. DEFINITIONS
p.000005: Considering aspects peculiar to medical devices, the following definitions will be considered according to ISO
p.000005: 14155/2011:
p.000005: Adverse Device Effect (EAD)
p.000005: Adverse event related to the use of a medical device under investigation. NOTE 1- Includes any event
p.000005: adverse effect resulting from insufficiencies or deficiencies in the instructions for use, positioning,
p.000005: implantation, installation, operation, or any malfunction of the medical device in
p.000005: investigation.
p.000005: NOTE 2- includes any event that results from an error of use or intentional misuse.
p.000005: Adverse Event (EA)
p.000005: Any unfavorable medical event, unintentional injury, injury or undesirable clinical signs
p.000005: (including an abnormal laboratory finding) in research participants, users, or others,
p.000005: related or not to the medical device under investigation.
p.000005: NOTE 1: includes events related to the research device or comparator.
p.000005: NOTE 2: includes events related to the procedures involved (any procedure in the investigation protocol
p.000005: clinic).
p.000005: Medical Device Deficiencies
p.000005: The deficiency or inadequacy of a medical device related to its identity, quality,
p.000005: durability, reliability, safety or performance, such as malfunction, misuse or
p.000005: improper use and labeling.
p.000005: Medical device under investigation - medical device under test, object of the DICD, to be used in the test
...
p.000014: RESEARCH DOCTORS
p.000014: 13. PROCESS FLOWCHART
p.000014: ➢ ADVERSE EVENTS NOTIFICATION FLOWCHART IN CLINICAL TRIALS
p.000015: 15
p.000015: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000015: RESEARCH DOCTORS
p.000015: 14. FLOW CHART TO PROVIDE GUIDELINES TO CATEGORIZE ADVERSE EVENTS AND DISABILITIES OF THE
p.000015: DEVICE*. * such guidelines are not intended to show the interrelation of categories
p.000015: ADVERSE EVENT
p.000015: Does it meet the severity criteria?
p.000015: No
p.000015: Is it related to the device / procedure?
p.000015: No
p.000015: ADVERSE EVENT (EA)
p.000015: Yes
p.000015: Yes
p.000015: Serious Adverse Event (EAG)
p.000015: Adverse Device Effect (EAD)
p.000015: Is it related to the device / procedure?
p.000015: Yes
p.000015: Severe Adverse Effect of the Device (EAGD)
p.000015: IS
p.000015: expected?
p.000015: No
p.000015: Serious Unexpected Adverse Effect of the Device (EAIGD)
p.000016: 16
p.000016: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000016: RESEARCH DOCTORS
p.000016: 15. ANNEXES
p.000016: 15. 1 WHO-UMC SYSTEM FOR STANDARDIZED CAUSALITY ASSESSMENT
p.000016: 15.1.1 Table 1. Advances and limitations of the system for standardized causality assessment
p.000016: What can causality assessment do?
p.000016: What can't the causality assessment do?
p.000016: Decrease disagreement between evaluators Provide accurate quantitative measure of
p.000016: probability relationship
p.000016: Classify probability relation Distinguish between valid and invalid cases
p.000016: Mark reports individually To prove the relationship between the intervention and the
p.000016: event
p.000016: Improve scientific, educational assessment
p.000016: Quantify the contribution of the intervention to the development of an adverse event
p.000016: Changing uncertainties to certainties
p.000017: 17
p.000017: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000017: RESEARCH DOCTORS
p.000017: 15.1.2 Box 2. WHO-UMC Causal categories
p.000017: Categories + Criteria in the assessment of causality ++
p.000017: • Event or alteration (abnormal) in laboratory examination with a plausible temporal relationship in relation to the administration of
p.000017: intervention;
p.000017: • Cannot be explained by illness or other intervention, medication;
p.000017: Right / Defined
p.000017: Likely
p.000017: Possible
p.000017: Unlikely
p.000017: Conditional / Unclassified
p.000017: • Response to plausible interruption or withdrawal (pharmacologically, pathologically);
p.000017: • Pharmacologically or phenomenologically defined event (i.e. an objective and specific disorder or phenomenon
p.000017: pharmacologically recognized);
p.000017: • Satisfactory restocking, if necessary.
p.000017: • Event or alteration (abnormal) in laboratory examination with reasonable temporal relation to the administration of
p.000017: intervention;
p.000017: • Unlikely to be attributed to a disease or other intervention, medication;
p.000017: • Response to clinically reasonable interruption or withdrawal;
p.000017: • Reexposure not required.
p.000017: • Event or alteration (abnormal) in laboratory examination with reasonable temporal relation to the administration of
p.000017: intervention;
p.000017: • It can also be explained by illness or other interventions, drugs;
p.000017: • Information about withdrawing or stopping treatment may be missing or unclear.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000005: adverse effect resulting from insufficiencies or deficiencies in the instructions for use, positioning,
p.000005: implantation, installation, operation, or any malfunction of the medical device in
p.000005: investigation.
p.000005: NOTE 2- includes any event that results from an error of use or intentional misuse.
p.000005: Adverse Event (EA)
p.000005: Any unfavorable medical event, unintentional injury, injury or undesirable clinical signs
p.000005: (including an abnormal laboratory finding) in research participants, users, or others,
p.000005: related or not to the medical device under investigation.
p.000005: NOTE 1: includes events related to the research device or comparator.
p.000005: NOTE 2: includes events related to the procedures involved (any procedure in the investigation protocol
p.000005: clinic).
p.000005: Medical Device Deficiencies
p.000005: The deficiency or inadequacy of a medical device related to its identity, quality,
p.000005: durability, reliability, safety or performance, such as malfunction, misuse or
p.000005: improper use and labeling.
p.000005: Medical device under investigation - medical device under test, object of the DICD, to be used in the test
p.000005: for the purpose of obtaining information for your registration or post-registration.
p.000006: 6
p.000006: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000006: RESEARCH DOCTORS
p.000006: NOTE: includes medical devices already on the market that are being evaluated for new uses
p.000006: new populations, new materials or design changes.
p.000006: Serious Adverse Event (EAG)
p.000006: One that results in any adverse experience with medical devices, occurring in and that results in
p.000006: any of the following outcomes:
p.000006: a) death;
p.000006: b) potentially fatal adverse event (one that, in the opinion of the notifier, places the individual under
p.000006: immediate risk of death due to the adverse event that occurred);
p.000006: c) persistent or significant disability / disability;
p.000006: d) requires hospitalization of the patient or prolongs hospitalization;
p.000006: e) congenital anomaly or birth defect;
p.000006: f) any suspicion of transmission of an infectious agent by means of a medical device;
p.000006: g) clinically significant event.
p.000006: NOTE 1: includes device deficiencies that could have led to a serious adverse event, if a) measures
p.000006: appropriate measures had not been taken or b) the intervention had not been carried out or c) if the circumstances
p.000006: had been less favorable. These are addressed within the scope of the event communication system
p.000006: serious adverse events.
p.000006: NOTE 2: Hospitalization planned for a pre-existing condition, or a procedure required by the
p.000006: Clinical Investigation Plan, without a serious deterioration of health, is not considered an adverse event
p.000006: serious.
p.000006: Severe Adverse Effect of the Device (EAGD)
p.000006: Adverse effect related to the device that resulted in any of the characteristic consequences of
p.000006: a serious adverse event.
p.000007: 7
p.000007: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000007: RESEARCH DOCTORS
p.000007: Serious Unexpected Adverse Effect of the Device (EAIGD)
p.000007: Serious adverse effect of the device that, by its nature, incidence, severity or consequences has not been identified
p.000007: in the most current version of the risk analysis report.
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000010: 10. WHEN NOT TO NOTIFY THE ADVERSE EVENT TO ANVISA
p.000010: The adverse event need not be notified to Anvisa when it occurs outside the national territory and when the
p.000010: adverse event is defined in the clinical trial protocol as a primary or secondary outcome.
p.000011: 11
p.000011: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000011: RESEARCH DOCTORS
p.000011: 11. QUALIFICATION GRADE OF QUALIFICATION FOR HEALTH CONDITIONS (WHO)
p.000011: Light
p.000011: A problem is present less than 25% of the time, with an intensity that a person can tolerate and that rarely
p.000011: happens in the last 30 days.
p.000011: Moderate
p.000011: It means that a problem that is present less than 50% of the time, with an intensity that interferes with the day-to-day
p.000011: people and that happens occasionally in the last 30 days.
p.000011: Severe
p.000011: It means that a problem that is present more than 50% of the time, with an intensity that changes
p.000011: partly the day-to-day lives of people and which often happens in the last 30 days.
p.000011: Complete commitment
p.000011: It means that a problem that is present more than 95% of the time, with an intensity that completely changes the
p.000011: person's day-to-day life and which occurs every day for the last 30 days.
p.000011: Not specified
p.000011: It means that there is not enough information to specify the intensity.
p.000011: Not applicable
p.000011: It means that it is inappropriate to use a gradation (eg menstrual functions).
p.000012: 12
p.000012: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000012: RESEARCH DOCTORS
p.000012: 12. BIBLIOGRAPHIC REFERENCES
p.000012: 1. ACKER JE 3rd, Pancioli AM, Crocco TJ, et al. Implementation strategies for emergency medical services
p.000012: within stroke systems of care: a policy statement from the American Heart Association / American Stroke
p.000012: Association Expert Panel on Emergency Medical Services Systems and the Stroke Council. Stroke 2007; 38: 3097–3115.
p.000012: 2. BASTOS, Alessandra Soler et al. Time of arrival of the patient with acute myocardial infarction in a
p.000012: emergency. Rev Bras Cir Cardiovasc, São José do Rio Preto, v. 27, n. 3, Sept. 2012. Available at:
p.000012: accessed on: 19 ago. 2014
p.000012: http://dx.doi.org/10.5935/1678- 9741.20120070.
p.000012: 3. International Organization for Standardization - ISO 14155: 2011 Clinical investigation of medical
p.000012: devices for human subjects - Good clinical practice available at <
p.000012: http://www.iso.org/iso/catalogue_detail?csnumber=45557>
p.000012: 4. MINISTRY OF HEALTH, WORLD HEALTH ORGANIZATION. Operational Guidelines for Establishment and Operation
p.000012: of Data and Security Monitoring Committees. Series A. Standards and Technical Manuals. Available in:
p.000012: Accessed on June 3. 2014.
p.000012: 5. THE UPPSALA MONITORING CENTER. WHO Collaborating Center for International Drug Monitoring. Glossary of Terms in
p.000012: Pharmacovigilance. Available at: . Accessed on Jun. 3 2014.
p.000013: 13
p.000013: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000013: RESEARCH DOCTORS
p.000013: 6. THE UPPSALA MONITORING CENTER. WHO Collaborating Center for International Drug Monitoring. WHO-UMC Causality
p.000013: Assessment. Available in:
p.000013: . Accessed on Jun. 3 2014.
p.000014: 14
p.000014: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000014: RESEARCH DOCTORS
p.000014: 13. PROCESS FLOWCHART
p.000014: ➢ ADVERSE EVENTS NOTIFICATION FLOWCHART IN CLINICAL TRIALS
p.000015: 15
...
Orphaned Trigger Words
p.000007: in the most current version of the risk analysis report.
p.000007: NOTE: “expected or anticipated” is characterized as an effect that, by its nature, incidence, severity or
p.000007: consequences was previously identified in the risk analysis report.
p.000007: 4. LEGAL BASIS
p.000007: Anvisa Resolution - RDC nº 10, of February 20, 2015, which provides for regulation for the realization of
p.000007: clinical trials with medical devices in Brazil.
p.000007: 5. OBJECTIVE
p.000007: Without prejudice to the existing provisions in the legal provisions, this manual aims to guide
p.000007: both the process of reporting unexpected serious adverse events to ANVISA, as well as establishing
p.000007: criteria and definitions relevant to filling in data on adverse events in reports
p.000007: follow-up of clinical trials.
p.000007: 6. MONITORING OF ADVERSE EVENTS (EA`s)
p.000007: It is the sponsor's responsibility to collect and monitor all adverse events, including those not
p.000007: serious, classifying them according to Chart 2 of the WHO-UMC System for standardized assessment of causality
p.000007: (Annex I). Late adverse events must present an established monitoring plan.
p.000007: All adverse events must be treated and affected participants accompanied by the principal investigator
p.000007: and your team until their resolution or stabilization. In the event of a serious adverse event, the sponsor and the investigator
p.000007: should take immediate security measures to protect
p.000008: 8
p.000008: MANUAL FOR NOTIFICATION OF ADVERSE EVENTS AND SECURITY MONITORING IN CLINICAL TRIALS INVOLVING DEVICES
p.000008: RESEARCH DOCTORS
p.000008: clinical trial participants against any imminent risk and the sponsor must notify Anvisa
p.000008: and describe the measures adopted in the Form for notification of EAGs in Clinical Trials with Devices
p.000008: Doctors: available at the link: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=28308
p.000008: The analysis of aggregated data of adverse events that occurred in clinical trials is part of the monitoring.
p.000008: 7. EAG`s NOTIFICATION (FORMSUS)
p.000008: For regulatory submission purposes, the sponsor is required to report serious adverse events,
p.000008: unexpected occurrences in the national territory, whose relationship with the product under investigation is possible, probable
p.000008: or defined.
p.000008: a) The recommended criteria for the individual categorization of each event into possible, probable, defined, improbable,
p.000008: conditional or inaccessible is the WHO-UMC system for standardized assessment of causality;
p.000008: b) Other methods can be used for categorization provided that correspondence with the system is proven
p.000008: WHO-UMC;
p.000008: c) Suspected Unexpected Serious Adverse Reaction (SUSAR) is included in the criteria for
p.000008: notification of a serious adverse event and must be notified, however, the criteria listed in the DRC are not limited to
p.000008: he.
p.000008: d) Notifications must be made exclusively through the electronic form
p.000008: “Notification of EAGs in Clinical Trials with Medical Devices - NotivisaEC-DISPOSITIVOS”,
p.000008: available at the link: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=28308:
p.000008: ➢ Some pages of the form may take a long time to load, please wait;
p.000008: ➢ It is not necessary to log in to notify adverse events;
p.000008: ➢ After completing the last page, a protocol number and a mirror of the
p.000008: notification. Keep this number to update your notification;
p.000009: 9
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| disability | Mentally Disabled |
| drug | Drug Usage |
| educational | education |
| emergency | Public Emergency |
| illness | Physically Disabled |
| opinion | philosophical differences/differences of opinion |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input