0A4F4F9BD490A749D5437F821CF06DF1
Circular No 600-5776-14: Processes of Good Clinical Practice
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Examining the file media/Synopses/29BAEF051A1DE58D1F840072E169A471.html:
This file was generated: 2020-07-15 04:29:09
| 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
Political / political affiliation
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p.004083: that includes microbial contamination, absence of active principle) less than 6 months after its completion.
p.004083: When any medicine (with an approved health record or under investigation) that
p.004083: it will be used or conditioned (formulated or packaged) in a different way from that approved or when
p.004083: used to obtain more information about a previous use, the studies of
p.004083: stability.
p.004083: Bcgo! U? OloiTiLi ‹I
p.004083: ›Y’ ‘’ / ›fi iÚ '/ ü' 0 f'0Y (0
p.004083: PROSPERITY
p.004083: #FOR ALL
p.004083: 600-5776-14
p.004083: 4. Related to the Guide annual report of research protocols Code: PM01-RS- G47, it is reported:
p.004083: The annual report of each protocol must be submitted to Invima taking into account the date of approval of the study
p.004083: clinic in the country, which corresponds until 2013, to the date of issue of the certificate issued by the
p.004083: Review Commission where it recommends approving the protocol; as of 2014, it is considered as the date of
p.004083: approval, the date of execution of the administrative act of approval issued by the DMPB. It is reiterated
p.004083: that you have a maximum of 30 calendar days after the end of the approval year, to notify the
p.004083: report.
p.004083: Interested parties are reminded that those clinical studies that are active and take more than a year
p.004083: since their approval, they must submit a single annual report listing all the information from the years of
p.004083: protocol development.
p.004083: 5. It should be borne in mind that any submission involving drug research protocols
p.004083: and related documents must be done in the updated formats, otherwise they will not be
p.004083: evaluated and will be returned to the interested party.
p.004083: These formats are available on the Invima website at the following links:
p.004083: https://www.invima.qov.co/index.ühp?oütion=com content & view = articIe & id = 986: formats-
p.004083: for-the-presentation-of-documents-related-to-research-protocols-qrupo-
p.004083: of-good-clinical-practices-bpc & catid = 225: good-clinical-practices & ltemid = 381
p.004083: https://www.invima.qov.co/index.php?option=com content & view = article & id = 994: report-
p.004083: of-adverse-events & catid = 225: good-clinical-practices & Itemid = 385
p.004083: https://www.invima.qov.co/index.php?option=com content & view = articIe & id = 2983% 3Ainfor
p.004083: me-anuaI-de-protocoIos-de-investisacion & catid = 225% 3Abuenas-practices-clinics & Itemid = 326
p.004083: All documentation submitted to Invima must be individually related, that is to say
p.004083: the submission of each document must be separately and have its own filing number
p.004083: (IPS, investigators, amendments, Informed Consents, among others).
p.004083: 6. Finally, the Directorate of Medicines and Biological Products recalls the rates found
p.004083: established for processes related to clinical research, through Resolution No. 2014026516
p.004083: of August 19, 2014. "By which the rates are updated in INVIMA", in which they were created and
p.004083: updated referring rates with the processes of Clinical Trials and Good Clinical Practices,
p.004083: demarcated below:
p.004083: (onero68D N 'l7 lllÍl
p.004083: ^ PPRAORSAPTEORDIDOASD
p.004083: 600-5776-14
p.004083: CODE 4010
p.004083: 4083
p.004089: 4089
p.004089: CONCEPT
p.004089: Visits to certify renew the Good Clinical Practices in the institutions where they are carried out
p.004089: research with human beings, through the application and use of medications Evaluation of amendments to
p.004089: pharmacological research protocols
p.004089: Visit to verify new conditions in the certification of
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.004083: ) Í ") lÍ” "/") ÉÜ IPPAROeSAPTERoInDoAsD
p.004083: CIRCULAR
p.004083: FROM:
p.004083: 600-5776-14
p.004083: DIRECTION OF MEDICINES AND BIOLOGICAL PRODUCTS
p.004083: TO: CL STUDY SPONSORS (NICOS, CONTRACT RESEARCH ORGANIZATIONS
p.004083: (OIC) AND INSTITUTIONS THAT DEVELOP RESEARCH WITH MEDICINES IN BEINGS
p.004083: HUMANS.
p.004083: SUBJECT: PROCESSES OF GOOD CLINICAL PRACTICES - PCB. DATE: DECEMBER 1, 2014
p.004083: In the first instance, it is recalled that pursuant to Resolution 2378 of 2008, “By which the Good
p.004083: Clinical Practices for the institutions that conduct research with medicines in human beings ", the
p.004083: approval and interruption of clinical research protocols and activities will be in charge of the
p.004083: National Institute for Food and Drug Surveillance Invima, according to the articles mentioned
p.004083: then:
p.004083: ARzicuLO s.- 'APPROVAL OF PROxEcros.- Clinical research projects may not be started
p.004083: with drugs in humans, which are not approved by the National Surveillance Institute of
p.004083: Medicines and Food - INVIMA, or that have not obtained a prior approval by said Institute ”.
p.004083: a RícuLO 6 .- "INTERRUPTION OF INVESTIGATIONS. - The National Institute for Food and Drug Surveillance -
p.004083: INVIMA, may at any time interrupt the performance of a clinical investigation or demand the
p.004083: introduction of modifications to your project, in the following cases. ”
p.004083: a) Alteration of the authorization conditions.
p.004083: b) Breach of Good Clinical Practices.
p.004083: c) Protection of human subjects test subjects.
p.004083: d) Defense of public health.
p.004083: PARAGRAPH.- The favorable or unfavorable results of each clinical investigation, whether it reaches its
p.004083: order as if abandoned, must be reported to the National Institute of Food and Drug Surveillance -
p.004083: INVIMA. ”
p.004083: On the other hand, in response to the different requests related to the
p.004083: evaluation and monitoring of research protocols, Invima requires specifying the
p.004083: Institutions that provide Health Services (IPS) certified in Good Clinical Practice, the following:
p.004083: Conera £ 8DN ° l7lZ)
p.004083: f'g \ 2948 / @
p.004083: IPPAROIiSAP ¥ EORI0DOADS
p.004083: 600-5776-14
p.004083: 1. Regarding the evaluation procedure of clinical trials, what is related in the Guide for the
p.004083: evaluation and monitoring of research protocols code PM01-RS- G45:
p.004083: 1.1 Approval of Protocols: As established in the guide, “The evaluation decision made
p.004083: of the protocol (approval or not), will be notified to the sponsor through an administrative act issued
p.004083: by the Directorate of Medicines and Biological Products (DMPB), where the
p.004083: specific characteristics of the protocol, therefore it will not be possible to initiate research activities specific to the
p.004083: protocol until such document is not available.
p.004083: 1.2 Phase IV Clinical Studies: Regarding Phase IV clinical trial protocols, they should only be submitted to
p.004083: this Institute those clinical studies that present intervention in the study groups, such as
p.004083: for example, trials with randomized treatments, which adopt the characteristics
p.004083: from a clinical study.
p.004083: 1.3 Notification of deviations: It is recalled that the deviations presented during development
p.004083: of the research protocols, must be notified only in Spanish language to
p.004083: via email invimabpc@invima.gov.co in Excel format and at one time
p.004083: maximum of 15 business days from when the Sponsor / CRO / OlC becomes aware, as
...
p.004083: We inform that to date you must have authorization from INVIMA so that they can
p.004083: be implemented and conducted, that is, that no IPS and Researcher may carry out a study without having
p.004083: previously the authorization of this Institute, as well as the changes in the
p.004083: informed consent or amendments, until these are reviewed and approved by INVIMA through
p.004083: of the group of Good Clinical Practices.
p.004083: PROSPERITY
p.004083: IPARATODOS
p.004083: 600-5776-14
p.004083: The sub-investigators must not be submitted to Invima, with the exception of those established in the “
p.004083: GUIDE FOR THE SELECTION OF THE PRINCIPAL INVESTIGATOR ”Code. PM01-RS-G44.
p.004083: 2. Related to the Guide for medicines and clinical research supplies, code PM01-RS-G51.
p.004083: Re-labeling processes:
p.004083: As stated in the guide, re-labeling as a conditioning process
p.004083: secondary must be done in a Pharmaceutical Laboratory that has a certificate in Good Practices of
p.004083: Manufacturing, Logistics Operator centers that have Good Manufacturing Practices for
p.004083: secondary conditioning or in Health Service Provider Institutions (IPS) that have Good
p.004083: Elaboration practices for repackaging and / or repackaging processes. The above in accordance with the regulations
p.004083: established national: Resolution 3183 of 1995, Resolution 3028 of 2008 and
p.004083: Resolution 444 of 2008.
p.004083: When the re-labeling is related to the extension of the product's shelf life in
p.004083: research, it is recommended that requests be made with at least three
p.004083: (3) months before the expiration of the product under investigation, in the same way it is recalled that according to
p.004083: established by the World Health Organization for drug stability studies,
p.004083: Colombia is classified as Climate Zone IV B. The presentation of the stability study
p.004083: must be done with the tabulated results of natural stability of at least 2 batches of the
p.004083: research product.
p.004083: 3. Related to the “Guide for the presentation of research protocols” Code PM01-RS-G36
p.004083: Number 4. Guidelines for the presentation of literal research protocols h) Time of useful life
p.004083: w / bow / act (Results of research product stability studies supporting life
p.004083: and the certificate of analysis of the batch of the product with which the study will be carried out in the country).
p.004083: It should be remembered that an investigational product is understood as a pharmaceutical form of a
p.004083: active ingredient or placebo that is being tested or used as a reference in a clinical study,
p.004083: including products with marketing authorization. When you submit a new protocol with
p.004083: a new molecule that does not yet have a sanitary registry, it is necessary to include stability studies,
p.004083: in the case of using placebo in the study, a certificate of analysis must be attached (minimum of two batches,
p.004083: that includes microbial contamination, absence of active principle) less than 6 months after its completion.
p.004083: When any medicine (with an approved health record or under investigation) that
p.004083: it will be used or conditioned (formulated or packaged) in a different way from that approved or when
p.004083: used to obtain more information about a previous use, the studies of
p.004083: stability.
p.004083: Bcgo! U? OloiTiLi ‹I
p.004083: ›Y’ ‘’ / ›fi iÚ '/ ü' 0 f'0Y (0
p.004083: PROSPERITY
p.004083: #FOR ALL
p.004083: 600-5776-14
p.004083: 4. Related to the Guide annual report of research protocols Code: PM01-RS- G47, it is reported:
p.004083: The annual report of each protocol must be submitted to Invima taking into account the date of approval of the study
p.004083: clinic in the country, which corresponds until 2013, to the date of issue of the certificate issued by the
p.004083: Review Commission where it recommends approving the protocol; as of 2014, it is considered as the date of
p.004083: approval, the date of execution of the administrative act of approval issued by the DMPB. It is reiterated
p.004083: that you have a maximum of 30 calendar days after the end of the approval year, to notify the
p.004083: report.
p.004083: Interested parties are reminded that those clinical studies that are active and take more than a year
p.004083: since their approval, they must submit a single annual report listing all the information from the years of
p.004083: protocol development.
p.004083: 5. It should be borne in mind that any submission involving drug research protocols
p.004083: and related documents must be done in the updated formats, otherwise they will not be
p.004083: evaluated and will be returned to the interested party.
p.004083: These formats are available on the Invima website at the following links:
p.004083: https://www.invima.qov.co/index.ühp?oütion=com content & view = articIe & id = 986: formats-
p.004083: for-the-presentation-of-documents-related-to-research-protocols-qrupo-
p.004083: of-good-clinical-practices-bpc & catid = 225: good-clinical-practices & ltemid = 381
p.004083: https://www.invima.qov.co/index.php?option=com content & view = article & id = 994: report-
p.004083: of-adverse-events & catid = 225: good-clinical-practices & Itemid = 385
p.004083: https://www.invima.qov.co/index.php?option=com content & view = articIe & id = 2983% 3Ainfor
p.004083: me-anuaI-de-protocoIos-de-investisacion & catid = 225% 3Abuenas-practices-clinics & Itemid = 326
p.004083: All documentation submitted to Invima must be individually related, that is to say
p.004083: the submission of each document must be separately and have its own filing number
p.004083: (IPS, investigators, amendments, Informed Consents, among others).
p.004083: 6. Finally, the Directorate of Medicines and Biological Products recalls the rates found
p.004083: established for processes related to clinical research, through Resolution No. 2014026516
p.004083: of August 19, 2014. "By which the rates are updated in INVIMA", in which they were created and
p.004083: updated referring rates with the processes of Clinical Trials and Good Clinical Practices,
p.004083: demarcated below:
p.004083: (onero68D N 'l7 lllÍl
p.004083: ^ PPRAORSAPTEORDIDOASD
p.004083: 600-5776-14
p.004083: CODE 4010
p.004083: 4083
p.004089: 4089
p.004089: CONCEPT
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.004083: PARAGRAPH.- The favorable or unfavorable results of each clinical investigation, whether it reaches its
p.004083: order as if abandoned, must be reported to the National Institute of Food and Drug Surveillance -
p.004083: INVIMA. ”
p.004083: On the other hand, in response to the different requests related to the
p.004083: evaluation and monitoring of research protocols, Invima requires specifying the
p.004083: Institutions that provide Health Services (IPS) certified in Good Clinical Practice, the following:
p.004083: Conera £ 8DN ° l7lZ)
p.004083: f'g \ 2948 / @
p.004083: IPPAROIiSAP ¥ EORI0DOADS
p.004083: 600-5776-14
p.004083: 1. Regarding the evaluation procedure of clinical trials, what is related in the Guide for the
p.004083: evaluation and monitoring of research protocols code PM01-RS- G45:
p.004083: 1.1 Approval of Protocols: As established in the guide, “The evaluation decision made
p.004083: of the protocol (approval or not), will be notified to the sponsor through an administrative act issued
p.004083: by the Directorate of Medicines and Biological Products (DMPB), where the
p.004083: specific characteristics of the protocol, therefore it will not be possible to initiate research activities specific to the
p.004083: protocol until such document is not available.
p.004083: 1.2 Phase IV Clinical Studies: Regarding Phase IV clinical trial protocols, they should only be submitted to
p.004083: this Institute those clinical studies that present intervention in the study groups, such as
p.004083: for example, trials with randomized treatments, which adopt the characteristics
p.004083: from a clinical study.
p.004083: 1.3 Notification of deviations: It is recalled that the deviations presented during development
p.004083: of the research protocols, must be notified only in Spanish language to
p.004083: via email invimabpc@invima.gov.co in Excel format and at one time
p.004083: maximum of 15 business days from when the Sponsor / CRO / OlC becomes aware, as
p.004083: stated in the guide mentioned. All deviations must be reported, filed, as well as
p.004083: those presented in phase IV studies with intervention.
p.004083: 1.4 Amendments to the protocol: In the cases in which an amendment is submitted, it requires the
p.004083: update of the informed consent of the clinical study, the documents must be filed from
p.004083: jointly.
p.004083: All approvals of the amendments must be submitted simultaneously by the
p.004083: ethics committees.
p.004083: This type of procedure must be notified to the Group of Good Clinical Practices, who will assess the
p.004083: relevance of the same and according to this evaluation will submit it to analysis by the Specialized Chamber of Medicines
p.004083: and Biological Products.
p.004083: When the amendment involves the safety of the research subject, it must be applied after approval by
p.004083: part of the ethics committee and then submit to INVIMA. In these cases it is necessary that the committees
p.004083: of ethics give priority to this evaluation.
p.004083: 1.5 Regarding the submission of Amendments, IPS, Informed Consents and investigators,
p.004083: We inform that to date you must have authorization from INVIMA so that they can
p.004083: be implemented and conducted, that is, that no IPS and Researcher may carry out a study without having
p.004083: previously the authorization of this Institute, as well as the changes in the
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.004083: including products with marketing authorization. When you submit a new protocol with
p.004083: a new molecule that does not yet have a sanitary registry, it is necessary to include stability studies,
p.004083: in the case of using placebo in the study, a certificate of analysis must be attached (minimum of two batches,
p.004083: that includes microbial contamination, absence of active principle) less than 6 months after its completion.
p.004083: When any medicine (with an approved health record or under investigation) that
p.004083: it will be used or conditioned (formulated or packaged) in a different way from that approved or when
p.004083: used to obtain more information about a previous use, the studies of
p.004083: stability.
p.004083: Bcgo! U? OloiTiLi ‹I
p.004083: ›Y’ ‘’ / ›fi iÚ '/ ü' 0 f'0Y (0
p.004083: PROSPERITY
p.004083: #FOR ALL
p.004083: 600-5776-14
p.004083: 4. Related to the Guide annual report of research protocols Code: PM01-RS- G47, it is reported:
p.004083: The annual report of each protocol must be submitted to Invima taking into account the date of approval of the study
p.004083: clinic in the country, which corresponds until 2013, to the date of issue of the certificate issued by the
p.004083: Review Commission where it recommends approving the protocol; as of 2014, it is considered as the date of
p.004083: approval, the date of execution of the administrative act of approval issued by the DMPB. It is reiterated
p.004083: that you have a maximum of 30 calendar days after the end of the approval year, to notify the
p.004083: report.
p.004083: Interested parties are reminded that those clinical studies that are active and take more than a year
p.004083: since their approval, they must submit a single annual report listing all the information from the years of
p.004083: protocol development.
p.004083: 5. It should be borne in mind that any submission involving drug research protocols
p.004083: and related documents must be done in the updated formats, otherwise they will not be
p.004083: evaluated and will be returned to the interested party.
p.004083: These formats are available on the Invima website at the following links:
p.004083: https://www.invima.qov.co/index.ühp?oütion=com content & view = articIe & id = 986: formats-
p.004083: for-the-presentation-of-documents-related-to-research-protocols-qrupo-
p.004083: of-good-clinical-practices-bpc & catid = 225: good-clinical-practices & ltemid = 381
p.004083: https://www.invima.qov.co/index.php?option=com content & view = article & id = 994: report-
p.004083: of-adverse-events & catid = 225: good-clinical-practices & Itemid = 385
p.004083: https://www.invima.qov.co/index.php?option=com content & view = articIe & id = 2983% 3Ainfor
p.004083: me-anuaI-de-protocoIos-de-investisacion & catid = 225% 3Abuenas-practices-clinics & Itemid = 326
p.004083: All documentation submitted to Invima must be individually related, that is to say
p.004083: the submission of each document must be separately and have its own filing number
p.004083: (IPS, investigators, amendments, Informed Consents, among others).
p.004083: 6. Finally, the Directorate of Medicines and Biological Products recalls the rates found
p.004083: established for processes related to clinical research, through Resolution No. 2014026516
p.004083: of August 19, 2014. "By which the rates are updated in INVIMA", in which they were created and
p.004083: updated referring rates with the processes of Clinical Trials and Good Clinical Practices,
p.004083: demarcated below:
p.004083: (onero68D N 'l7 lllÍl
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.004083: Re-labeling processes:
p.004083: As stated in the guide, re-labeling as a conditioning process
p.004083: secondary must be done in a Pharmaceutical Laboratory that has a certificate in Good Practices of
p.004083: Manufacturing, Logistics Operator centers that have Good Manufacturing Practices for
p.004083: secondary conditioning or in Health Service Provider Institutions (IPS) that have Good
p.004083: Elaboration practices for repackaging and / or repackaging processes. The above in accordance with the regulations
p.004083: established national: Resolution 3183 of 1995, Resolution 3028 of 2008 and
p.004083: Resolution 444 of 2008.
p.004083: When the re-labeling is related to the extension of the product's shelf life in
p.004083: research, it is recommended that requests be made with at least three
p.004083: (3) months before the expiration of the product under investigation, in the same way it is recalled that according to
p.004083: established by the World Health Organization for drug stability studies,
p.004083: Colombia is classified as Climate Zone IV B. The presentation of the stability study
p.004083: must be done with the tabulated results of natural stability of at least 2 batches of the
p.004083: research product.
p.004083: 3. Related to the “Guide for the presentation of research protocols” Code PM01-RS-G36
p.004083: Number 4. Guidelines for the presentation of literal research protocols h) Time of useful life
p.004083: w / bow / act (Results of research product stability studies supporting life
p.004083: and the certificate of analysis of the batch of the product with which the study will be carried out in the country).
p.004083: It should be remembered that an investigational product is understood as a pharmaceutical form of a
p.004083: active ingredient or placebo that is being tested or used as a reference in a clinical study,
p.004083: including products with marketing authorization. When you submit a new protocol with
p.004083: a new molecule that does not yet have a sanitary registry, it is necessary to include stability studies,
p.004083: in the case of using placebo in the study, a certificate of analysis must be attached (minimum of two batches,
p.004083: that includes microbial contamination, absence of active principle) less than 6 months after its completion.
p.004083: When any medicine (with an approved health record or under investigation) that
p.004083: it will be used or conditioned (formulated or packaged) in a different way from that approved or when
p.004083: used to obtain more information about a previous use, the studies of
p.004083: stability.
p.004083: Bcgo! U? OloiTiLi ‹I
p.004083: ›Y’ ‘’ / ›fi iÚ '/ ü' 0 f'0Y (0
p.004083: PROSPERITY
p.004083: #FOR ALL
p.004083: 600-5776-14
p.004083: 4. Related to the Guide annual report of research protocols Code: PM01-RS- G47, it is reported:
p.004083: The annual report of each protocol must be submitted to Invima taking into account the date of approval of the study
p.004083: clinic in the country, which corresponds until 2013, to the date of issue of the certificate issued by the
p.004083: Review Commission where it recommends approving the protocol; as of 2014, it is considered as the date of
p.004083: approval, the date of execution of the administrative act of approval issued by the DMPB. It is reiterated
p.004083: that you have a maximum of 30 calendar days after the end of the approval year, to notify the
p.004083: report.
p.004083: Interested parties are reminded that those clinical studies that are active and take more than a year
p.004083: since their approval, they must submit a single annual report listing all the information from the years of
p.004083: protocol development.
p.004083: 5. It should be borne in mind that any submission involving drug research protocols
p.004083: and related documents must be done in the updated formats, otherwise they will not be
...
Orphaned Trigger Words
p.004083: https://www.invima.qov.co/index.php?option=com content & view = articIe & id = 2983% 3Ainfor
p.004083: me-anuaI-de-protocoIos-de-investisacion & catid = 225% 3Abuenas-practices-clinics & Itemid = 326
p.004083: All documentation submitted to Invima must be individually related, that is to say
p.004083: the submission of each document must be separately and have its own filing number
p.004083: (IPS, investigators, amendments, Informed Consents, among others).
p.004083: 6. Finally, the Directorate of Medicines and Biological Products recalls the rates found
p.004083: established for processes related to clinical research, through Resolution No. 2014026516
p.004083: of August 19, 2014. "By which the rates are updated in INVIMA", in which they were created and
p.004083: updated referring rates with the processes of Clinical Trials and Good Clinical Practices,
p.004083: demarcated below:
p.004083: (onero68D N 'l7 lllÍl
p.004083: ^ PPRAORSAPTEORDIDOASD
p.004083: 600-5776-14
p.004083: CODE 4010
p.004083: 4083
p.004089: 4089
p.004089: CONCEPT
p.004089: Visits to certify renew the Good Clinical Practices in the institutions where they are carried out
p.004089: research with human beings, through the application and use of medications Evaluation of amendments to
p.004089: pharmacological research protocols
p.004089: Visit to verify new conditions in the certification of
p.004089: Good Clinical Practices
p.004089: DISCLAIMER:
p.004089: Rate 4089 refers to visits to verify new conditions in the certification of Good Practices
p.004089: Clinics of any of the base components and that have not been previously evaluated by this
p.004089: Institute. This applies to:
p.004089: • Change of headquarters of the research center
p.004089: • Change or inclusion of the pharmaceutical service
p.004089: • Change or inclusion of the clinical laboratory
p.004089: • Change or inclusion of a new ethics committee
p.004089: • Inclusion of a component of the certification in Good Clinical Practice All these rates apply from
p.004089: from the date of publication of the R esolution.
p.004089: This circular governs from the publication of the same.
p.004089: Sincerely,
p.004089: HEL NCO CHAPARRO LIGHT
p.004089: Director of Biological Products and Products
p.004089: Project: Professionals of the Clinical Trials Group - Special Programs VoBo Head of the Legal Advisory Office: R
p.004089: Esteban Garcia
p.004089: VoBo Special Pr Coordinator: A. Luna Legal VoBo D. Pulido
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| drug | Drug Usage |
| language | Linguistic Proficiency |
| party | political affiliation |
| placebo | participants in a control group |
| single | Marital Status |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
protection
Applicable Type / Vulnerability / Indicator Overlay for this Input