MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
No.62/QD-K2DT | Hanoi, June 02, 2017 |
DECISION
PROMULGATING GUIDELINE ON RECORDING, MANAGEMENT AND REPORTING OF AFVERSE EVENTS AND SERIOUS ADVERSE EVENTS IN CLINICAL TRIALS IN VIETNAM
DIRECTOR OF DEPARTMENT OF SCIENCE, TECHNOLOGY AND TRAINING
Pursuant to the Law on Pharmacy dated April 06, 2016;
Pursuant to Decree No.63/2012/ND-CP dated August 31, 2012 of the Government on functions, duties, rights and organizational structure of the Ministry of Health;
Pursuant to Decision No.4059/QD-BYT dated October 22, 2012 of the Minister of Health on functions, duties, rights and organizational structure of the Department of Science, Technology and Training affiliated to the Ministry of Health;
At the request of Head of the Division of Management of clinical trials and products thereof,
HEREBY DECIDES:
Article 1.“Guideline on recording, management and reporting of adverse events and serious adverse events in clinical trials in Vietnam” shall be issued together with this Decision.
Article 2.Trial facilities conducting clinical trials in Vietnam and organizations and individuals involved in recording, management and reporting of adverse events and serious adverse events shall adhere to the guideline provided herein to ensure the safety of trial participants.
Article 3.This Decision comes into force from the day on which it is signed.
Article 4.Directors of Departments, Chief Office of Departments, Heads of Divisions, departmental-affiliated entities, Directors of trial facilities conducting clinical trials and studies and relevant organizations and individuals shall take responsibility to implement this Decision./.
| PP. DIRECTOR |
GUIDELINE
RECORDING, MANAGEMENT AND REPORTING OF ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS IN CLINICAL TRIALS AND STUDIES IN VIETNAM
(Issued together with Decision No.62/QD-K2DT dated June 02, 2017)
1. General principles:
Recording, management and reporting of adverse events and serious adverse events in clinical trials and studies must adhere to international and Vietnamese guidelines on Good Clinical Practice (GCP).
This guideline applies for clinical trials on drugs (modern medicines, herbal ingredients, traditional drugs, vaccines, biological for disease prevention and treatment, bioavailability research and bioequivalence evaluation) medical equipment, new techniques and new methods for healthcare; studies on medical diagnosis and treatment methods, biological samples, epidemiology, sociology, psychology studies and non-experimental research after the study product are granted certificates of free sale in which trial participants are humans.
2. Definition and classification:
a) “adverse event” (hereinafter referred to as “AE") means medical occurrence, including any unintended sign, symptom, disease or testing result associated with the use of investigational products which cause a negative effect on trial participants and may be related or not related to medicinal products.
b) “serious adverse event” (hereinafter referred to as ‘SAE”) means any AE that:
b.1. results in death;
b2. is life-threatening;
b3. requires hospitalization or prolonged hospitalization;
b4. results in persistent or significant disability or incapacity;
b5. results in congenital anomaly/birth defect;
b.6 Other situations requiring appropriate medical intervention to prevent events specified in b1, b2, b3, b4 and b5 this Clause or other medical effects as considered by investigators at the trial site.
c) “unexpected AE” means any AE occurring during a clinical trial whose nature, seriousness, specificity or impact on the trial participant is different from that predicted or is not predicted in the trial protocol or relevant trial documents.
3. Reporting of AE/SAEs in clinical trials in Vietnam
3.1. Contents of the report on AE/SAE in clinical trials in Vietnam include:
a) Monitoring, detection and reporting of information relating to AEs/SAEs in clinical trials conducted in Vietnam and update on information and reports related to AEs/SAEs occurring outside of the territory of Vietnam within the multi-national clinical trial to which Vietnam is a participant as regulated;
b) Collection and processing of AE/SAE information reported, evaluation of benefits and risks and management of risks relating to clinical trials in which the AE/SAE is found;
c) Disclosure of conclusion on issues related to monitoring reports on AEs/SAEs in clinical trials made by competent authorities
3.2. Reporting scope:
a) All SAEs occurring in trial sites in Vietnam, especially SAEs that cause deaths or threaten life of trial participants or unexpected SAEs These SAEs also include failed investigational medical protocols that cause death or threaten life of the trial participants or need medical intervention to prevent aforementioned events.
b) SAEs occurring at trial sites outside of the territory of Vietnam within multi-national trial to which Vietnam is a participant that my lead to changes in the trial protocol, permanent or temporary suspension of trial conducted in any countries participating in the multi-national trial.
c) All AEs in clinical trials at trial sites in Vietnam
3.3. Reporting regulations
a) With regard to SAEs occurring at trial sites in Vietnam;
- All SAEs occurring at trial sites in Vietnam must be reported according to the report form provided in Appendix 1 issued thereto to the Human Trial Ethics Valuation Committee (Ministry of Health), Department of Science, Technology and Training (Ministry of Health) and National Center of Drug Information and Adverse Drug Reactions Monitoring.
- Reporting deadline: SAEs that cause death or threaten life of trial participants must be urgently reported with 7 working days from the day on which SAE information is received. Other SAEs must be reported within 15 working days from the day SAE information is received. All additional information with medical significance of SAE development, developments of the trial participant affected by the SAE or changes in causality between the SAE and the study product must be reported within 15 working days from the day such additional information is received.
a) With regard to SAEs occurring at trial sites outside the territory of Vietnam;
- All SAEs occurring at trial sites outside of the Vietnamese's territory in multi-national trial to which Vietnam is a participant that lead to changes in the trial protocol or permanent or temporary suspension of trial conducted in a country that participate in multi-national trial must be reported according to the report form provided in Appendix 1 issued thereto or the form issued by the Council for International Organizations of Medicals Science to the Department of Science, Technology and Training - Ministry of Health, Human Trial Ethics Evaluation Committee and National Center of Drug Information and Adverse Drug Reactions Monitoring.
- Reporting deadline: Such reports must be sent within 15 working days from the day on which information on decision on changes in the trial protocol, permanent or temporary suspension of trial conducted in a country participating to the multi-national trial is received.
c) Non-serious AEs occurring in Vietnam must be recorded, documented and specified in periodic report and full report on outcomes of the clinical trial sent to the Department of Science, Technology and Training – Ministry of Health and Human Trial Ethics Evaluation Committee – Ministry of Health.
3.4. Responsibilities for reporting AEs in clinical trials in Vietnam of entities concerned:
a) With regard to principal investigators and investigators at trial sites:
- Timely detect and manage AEs to ensure safety of trial participants, monitor and record all SAE information and reports and provide periodic updates on AEs and SAEs for organizations whose products are under clinical trial, local Human Trial Ethics Committee, Human Trial Ethics Evaluation Committee - Ministry of Health, Department of Science, Technology and Training - Ministry of Health and National Center of Drug Information and Adverse Drug Reactions Monitoring by the deadline. In case the frequency of AE/SAE occurrence is considered to excess the one predicted in the trial protocol or the study product dossier made by the investigator or user manual if the study product is granted certificate of free sale and considered to cause harm to the trial participant, the investigator may send a proposal of temporary suspension of trial to organizations whose products are under clinical trial, Human Trial Ethics Committee and competent authorities,
- Enroll on training course in improvement of knowledge about security report in clinical trials offered by the Ministry of Health or entities eligible to offer such training as permitted by the Ministry of Health.
b) Organizations conducting clinical trials shall manage and supervise detection, management and reporting of SAEs occurring at trial sites to ensure safety of trial participants.
c) The local Human Trial Ethics Committee shall consider and provide professional advice about SAEs occurring at trial sites to ensure absolute safety of trial participants.
d) Organizations or individuals whose products are under clinical trials and trial assistants shall be authorized to:
- cooperate with the principal investigator in reporting SAEs occurring at trial sites in Vietnam to the local Human Trial Ethics Committee, Human Trial Ethics Evaluation Committee - Ministry of Health, Department of Science, Technology and Training-Ministry of Health and National Center of Drug Information and Adverse Drug Reactions Monitoring.
- report SAEs occurring at trial sites outside of the territory of Vietnam within multi-national trial to which Vietnam is a participant that my lead to changes in the trial protocol, permanent or temporary suspension of trial conducted in any countries participating in the multi-national trial.
- make a consolidated report on AE/SAE information;
- provide updates on trial development and report findings from clinical trial, epidemiology trial, animal trial, in vitro experiments or information provided in medical journals or collected from other sources that hint potential risks related to the study products.
dd) The Human Trial Ethics Evaluation Committee-Ministry of Health shall:
- consider, evaluate and response to independent SAE reports and SAE information provided in the annual report and full report on outcomes of the clinical trial;
- carry out supervision and inspection of recording, analysis, management and reporting of SAEs occurring at trial sites periodically as predicted in the trial protocol or unexpectedly where necessary;
- Give advice for state management agencies in clinical trials so as for them to timely provide guidelines for the organizations conducting clinical trials and organization having products required to going through clinical trials to ensure absolute safety of trial participants.
e) The National Center of Drug Information and Adverse Drug Reactions Monitoring shall receive SAE reports in clinical trials, cooperate with the Human Trial Ethics Evaluation Committee – Ministry of Health in considering and evaluating SAE reports, aggregate and analyze data provided in such SAE report and send reports and proposals for ensuing safety of trial participants to the competent authority.
4. Management of AEs in clinical trials in Vietnam
a. In case the AE causes death or threatens life of the trial participant or is considered to harmful to the trial participant, the principal investigator and organization conducting clinical trial must immediately suspend the trial and work out solutions, and make record in case of death as well as notify the local Human Trial Ethics Committee, Human Trial Ethics Evaluation Committee - Ministry of Health, Department of Science, Technology and Training - Ministry of Health and National Center of Drug Information and Adverse Drug Reactions Monitoring as prescribed in Clause 3 herein.
b. In case the AE ruins the health of the trial participant, the principal investigator or the investigator in charge must provide treatment and monitor health condition of such participant until he/she completely recover and record as well as report such AE as prescribed in Clause 3 herein.
APPENDIX 1
Reporting code:…………………..
FORM OF REPORT ON SAEs IN CLINICAL TRIAL
1. ABSTRACT | 1. ABSTRACT | 1. ABSTRACT | 1. ABSTRACT | 1. ABSTRACT | 1. ABSTRACT | 1. ABSTRACT | 1. ABSTRACT | 1. ABSTRACT | ||||||||||||||||||||
Report type: | Report type: | □ | Initial report | Initial report | Initial report | □ | □ | Additional report | ||||||||||||||||||||
Classification by seriousness of the SAE: | Classification by seriousness of the SAE: | Classification by seriousness of the SAE: | Classification by seriousness of the SAE: | Classification by seriousness of the SAE: | Classification by seriousness of the SAE: | Classification by seriousness of the SAE: | Classification by seriousness of the SAE: | Classification by seriousness of the SAE: | ||||||||||||||||||||
□ | Death | □ | Life threatening | Life threatening | Life threatening |
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□ | Hospitalization/prolonged hospitalization | □ | Persistent or significant disability or incapacity | Persistent or significant disability or incapacity | Persistent or significant disability or incapacity | Persistent or significant disability or incapacity | Persistent or significant disability or incapacity | Persistent or significant disability or incapacity | ||||||||||||||||||||
□ | Congenital anomaly/birth defect | □ | Required medical intervention to prevent one of the aforesaid events or AE considered to have medical significance by the investigator in charge or principal investigator | Required medical intervention to prevent one of the aforesaid events or AE considered to have medical significance by the investigator in charge or principal investigator | Required medical intervention to prevent one of the aforesaid events or AE considered to have medical significance by the investigator in charge or principal investigator | Required medical intervention to prevent one of the aforesaid events or AE considered to have medical significance by the investigator in charge or principal investigator | Required medical intervention to prevent one of the aforesaid events or AE considered to have medical significance by the investigator in charge or principal investigator | Required medical intervention to prevent one of the aforesaid events or AE considered to have medical significance by the investigator in charge or principal investigator | ||||||||||||||||||||
Name of the trial | Name of the trial | Name of the trial | Name of the trial | ................................................................................. ................................................................................. | ................................................................................. ................................................................................. | ................................................................................. ................................................................................. | ................................................................................. ................................................................................. | ................................................................................. ................................................................................. | ||||||||||||||||||||
Trial design | Trial design | Trial design | Trial design | □ open-label | □ Single blind | □ Single blind | □ Double blind | □ Double blind | ||||||||||||||||||||
If this is a blind study, will SAE unblind it? | If this is a blind study, will SAE unblind it? | If this is a blind study, will SAE unblind it? | If this is a blind study, will SAE unblind it? | □ Yes | □ No | □ No | □ N/A | □ N/A | ||||||||||||||||||||
Sponsor | Sponsor | Sponsor | Sponsor | ................................................................................. | ................................................................................. | ................................................................................. | ................................................................................. | ................................................................................. | ||||||||||||||||||||
Name of the principal investigator | Name of the principal investigator | Name of the principal investigator | Name of the principal investigator | ................................................................................. | ................................................................................. | ................................................................................. | ................................................................................. | ................................................................................. | ||||||||||||||||||||
Trial site at which SAE is recorded | Trial site at which SAE is recorded | Trial site at which SAE is recorded | Trial site at which SAE is recorded | ................................................................................. | ................................................................................. | ................................................................................. | ................................................................................. | ................................................................................. | ||||||||||||||||||||
Time receiving SAE information | Time receiving SAE information | Time receiving SAE information | Time receiving SAE information | ................................................................................. | ................................................................................. | ................................................................................. | ................................................................................. | ................................................................................. | ||||||||||||||||||||
SAE occurrence time | SAE occurrence time | SAE occurrence time | SAE occurrence time | ................................................................................. | ................................................................................. | ................................................................................. | ................................................................................. | ................................................................................. | ||||||||||||||||||||
SAE end time (or check the “Ongoing” box if such SAE is ongoing) | SAE end time (or check the “Ongoing” box if such SAE is ongoing) | SAE end time (or check the “Ongoing” box if such SAE is ongoing) | SAE end time (or check the “Ongoing” box if such SAE is ongoing) | ......................................................... □ Ongoing | ......................................................... □ Ongoing | ......................................................... □ Ongoing | ......................................................... □ Ongoing | ......................................................... □ Ongoing | ||||||||||||||||||||
Name of the SAE (SAE diagnosis or main symptoms) | Name of the SAE (SAE diagnosis or main symptoms) | Name of the SAE (SAE diagnosis or main symptoms) | Name of the SAE (SAE diagnosis or main symptoms) | ................................................................................. | ................................................................................. | ................................................................................. | ................................................................................. | ................................................................................. | ||||||||||||||||||||
Abbreviated name of the trial participant | Abbreviated name of the trial participant | Abbreviated name of the trial participant | Abbreviated name of the trial participant | ................................................................................. | ................................................................................. | ................................................................................. | ................................................................................. | ................................................................................. | ||||||||||||||||||||
Trial participant code | Trial participant code | Trial participant code | Trial participant code | ................................................................................. | ................................................................................. | ................................................................................. | ................................................................................. | ................................................................................. | ||||||||||||||||||||
2. SAE DESCRIPTION AND RESPONSE | 2. SAE DESCRIPTION AND RESPONSE | 2. SAE DESCRIPTION AND RESPONSE | 2. SAE DESCRIPTION AND RESPONSE | 2. SAE DESCRIPTION AND RESPONSE | 2. SAE DESCRIPTION AND RESPONSE | 2. SAE DESCRIPTION AND RESPONSE | 2. SAE DESCRIPTION AND RESPONSE | 2. SAE DESCRIPTION AND RESPONSE | ||||||||||||||||||||
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Provide information on signs, clinical symptoms and clinical examination related to the SAE and response methods (if any), including suspension/reduction of dose of investigational products/medical protocol and development after such methods are adopted and other necessary information.
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Results of SAE response:
□ Recovery without complications □ Recovery with complications | □ Recovery without complications □ Recovery with complications | □ Recovery without complications □ Recovery with complications | □ Recovery without complications □ Recovery with complications | □ Recovery without complications □ Recovery with complications | □ In recovery □ Not recovery | □ In recovery □ Not recovery | □ In recovery □ Not recovery | □ Death (death date: …) □ N/A | □ Death (death date: …) □ N/A | □ Death (death date: …) □ N/A | □ Death (death date: …) □ N/A | |||||||||||||||||||||||||||||||||||||
3. CLINICAL TRIAL PARTICIPANT | 3. CLINICAL TRIAL PARTICIPANT | 3. CLINICAL TRIAL PARTICIPANT | 3. CLINICAL TRIAL PARTICIPANT | 3. CLINICAL TRIAL PARTICIPANT | 3. CLINICAL TRIAL PARTICIPANT | 3. CLINICAL TRIAL PARTICIPANT | 3. CLINICAL TRIAL PARTICIPANT | 3. CLINICAL TRIAL PARTICIPANT | 3. CLINICAL TRIAL PARTICIPANT | 3. CLINICAL TRIAL PARTICIPANT | 3. CLINICAL TRIAL PARTICIPANT | |||||||||||||||||||||||||||||||||||||
Date of birth | Date of birth | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | |||||||||||||||||||||||||||||||||||||
Age | Age | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | |||||||||||||||||||||||||||||||||||||
Gender | Gender | □ Male | □ Male | □ Female | □ Female | □ Female | For female: □ During pregnancy (week …) | For female: □ During pregnancy (week …) | For female: □ During pregnancy (week …) | For female: □ During pregnancy (week …) | For female: □ During pregnancy (week …) | |||||||||||||||||||||||||||||||||||||
Weight (Kg) | Weight (Kg) | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | |||||||||||||||||||||||||||||||||||||
Relevant disease history | Relevant disease history | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | ....................................................................................................... | |||||||||||||||||||||||||||||||||||||
4. MEDICINAL PRODUCT/MEDICAL PROTOCOL | 4. MEDICINAL PRODUCT/MEDICAL PROTOCOL | 4. MEDICINAL PRODUCT/MEDICAL PROTOCOL | 4. MEDICINAL PRODUCT/MEDICAL PROTOCOL | 4. MEDICINAL PRODUCT/MEDICAL PROTOCOL | 4. MEDICINAL PRODUCT/MEDICAL PROTOCOL | 4. MEDICINAL PRODUCT/MEDICAL PROTOCOL | 4. MEDICINAL PRODUCT/MEDICAL PROTOCOL | 4. MEDICINAL PRODUCT/MEDICAL PROTOCOL | 4. MEDICINAL PRODUCT/MEDICAL PROTOCOL | 4. MEDICINAL PRODUCT/MEDICAL PROTOCOL | 4. MEDICINAL PRODUCT/MEDICAL PROTOCOL | |||||||||||||||||||||||||||||||||||||
No. | Study product/medical protocol (a) | Study product/medical protocol (a) | Pharmaceutical formulation, content | Pharmaceutical formulation, content | Pharmaceutical formulation, content | Drug route | Drug route | Drug route | Dose | Use date (dd/mm/yy) | Use date (dd/mm/yy) | |||||||||||||||||||||||||||||||||||||
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ii |
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iii |
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iv |
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v |
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vi |
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(a) Specify the study product/medical protocol used by the trial participant. As for blinded study in which the SAE does not result in unblinding or identification of the study product/medical protocol used by the trial participant, specify the medical protocol applied in the trial and trial arm (described in section 2) (if information is available).
5. INTERVENTION IN STUDY PRODUCT/MEDICAL PRTOCOL AFTER SAE | 5. INTERVENTION IN STUDY PRODUCT/MEDICAL PRTOCOL AFTER SAE | 5. INTERVENTION IN STUDY PRODUCT/MEDICAL PRTOCOL AFTER SAE | 5. INTERVENTION IN STUDY PRODUCT/MEDICAL PRTOCOL AFTER SAE | 5. INTERVENTION IN STUDY PRODUCT/MEDICAL PRTOCOL AFTER SAE | 5. INTERVENTION IN STUDY PRODUCT/MEDICAL PRTOCOL AFTER SAE | 5. INTERVENTION IN STUDY PRODUCT/MEDICAL PRTOCOL AFTER SAE | 5. INTERVENTION IN STUDY PRODUCT/MEDICAL PRTOCOL AFTER SAE | 5. INTERVENTION IN STUDY PRODUCT/MEDICAL PRTOCOL AFTER SAE | 5. INTERVENTION IN STUDY PRODUCT/MEDICAL PRTOCOL AFTER SAE | |||||||||||||||
No. (b) | Is dose of study product/medical protocol used by the trial participant exposed to SAE completely cut or reduced? | Is dose of study product/medical protocol used by the trial participant exposed to SAE completely cut or reduced? | If the dose of study product/medical protocol is completely cut or reduced (or unblended), is the seriousness of the SAE played down? | If the dose of study product/medical protocol is completely cut or reduced (or unblended), is the seriousness of the SAE played down? | If the dose of study product/medical protocol is completely cut or reduced (or unblended), is the seriousness of the SAE played down? | If re-use the study product/medical protocol, will the SAE occur again? | If re-use the study product/medical protocol, will the SAE occur again? | If re-use the study product/medical protocol, will the SAE occur again? | If re-use the study product/medical protocol, will the SAE occur again? | |||||||||||||||
| Yes | No | Yes | No | N/A | Yes | No | N/A | No reuse | |||||||||||||||
i | □ | □ | □ | □ | □ | □ | □ | □ | □ | |||||||||||||||
ii | □ | □ | □ | □ | □ | □ | □ | □ | □ | |||||||||||||||
iii | □ | □ | □ | □ | □ | □ | □ | □ | □ | |||||||||||||||
iv | □ | □ | □ | □ | □ | □ | □ | □ | □ | |||||||||||||||
v | □ | □ | □ | □ | □ | □ | □ | □ | □ | |||||||||||||||
vi | □ | □ | □ | □ | □ | □ | □ | □ | □ | |||||||||||||||
(b) The No. stated as specified in section 4
6. DRUG/PRODUCT USED IN CONCURRENT WITH STUDY PRODUCT/MEDICAL PROTOCOL THAT MAY BE RELATED TO THE SAE AS JUDGED BY THE INVESTIGATOR (excluding drugs used for treating SAE) | 6. DRUG/PRODUCT USED IN CONCURRENT WITH STUDY PRODUCT/MEDICAL PROTOCOL THAT MAY BE RELATED TO THE SAE AS JUDGED BY THE INVESTIGATOR (excluding drugs used for treating SAE) | 6. DRUG/PRODUCT USED IN CONCURRENT WITH STUDY PRODUCT/MEDICAL PROTOCOL THAT MAY BE RELATED TO THE SAE AS JUDGED BY THE INVESTIGATOR (excluding drugs used for treating SAE) | 6. DRUG/PRODUCT USED IN CONCURRENT WITH STUDY PRODUCT/MEDICAL PROTOCOL THAT MAY BE RELATED TO THE SAE AS JUDGED BY THE INVESTIGATOR (excluding drugs used for treating SAE) | 6. DRUG/PRODUCT USED IN CONCURRENT WITH STUDY PRODUCT/MEDICAL PROTOCOL THAT MAY BE RELATED TO THE SAE AS JUDGED BY THE INVESTIGATOR (excluding drugs used for treating SAE) | 6. DRUG/PRODUCT USED IN CONCURRENT WITH STUDY PRODUCT/MEDICAL PROTOCOL THAT MAY BE RELATED TO THE SAE AS JUDGED BY THE INVESTIGATOR (excluding drugs used for treating SAE) | 6. DRUG/PRODUCT USED IN CONCURRENT WITH STUDY PRODUCT/MEDICAL PROTOCOL THAT MAY BE RELATED TO THE SAE AS JUDGED BY THE INVESTIGATOR (excluding drugs used for treating SAE) | 6. DRUG/PRODUCT USED IN CONCURRENT WITH STUDY PRODUCT/MEDICAL PROTOCOL THAT MAY BE RELATED TO THE SAE AS JUDGED BY THE INVESTIGATOR (excluding drugs used for treating SAE) | 6. DRUG/PRODUCT USED IN CONCURRENT WITH STUDY PRODUCT/MEDICAL PROTOCOL THAT MAY BE RELATED TO THE SAE AS JUDGED BY THE INVESTIGATOR (excluding drugs used for treating SAE) | 6. DRUG/PRODUCT USED IN CONCURRENT WITH STUDY PRODUCT/MEDICAL PROTOCOL THAT MAY BE RELATED TO THE SAE AS JUDGED BY THE INVESTIGATOR (excluding drugs used for treating SAE) | 6. DRUG/PRODUCT USED IN CONCURRENT WITH STUDY PRODUCT/MEDICAL PROTOCOL THAT MAY BE RELATED TO THE SAE AS JUDGED BY THE INVESTIGATOR (excluding drugs used for treating SAE) | 6. DRUG/PRODUCT USED IN CONCURRENT WITH STUDY PRODUCT/MEDICAL PROTOCOL THAT MAY BE RELATED TO THE SAE AS JUDGED BY THE INVESTIGATOR (excluding drugs used for treating SAE) | ||||||||||||||||||||||||||||
No. | No. | Drug/product used (original name and commercial name) | Drug/product used (original name and commercial name) | Pharmaceutical formulation, content | Pharmaceutical formulation, content | Drug route | Drug route | Dose | Use date (dd/mm/yy) | Use date (dd/mm/yy) | Use date (dd/mm/yy) | ||||||||||||||||||||||||||||
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1 | 1 |
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2 | 2 |
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3 | 3 |
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7. ASSESSMENT OF CAUSAL RELATIONSHIP BETWEEN THE SAE AND STUDY PRODUCT/MEDICAL PROTOCOL BY THE INVESTIGATOR/PRINCIPAL INVESTIGATOR | 7. ASSESSMENT OF CAUSAL RELATIONSHIP BETWEEN THE SAE AND STUDY PRODUCT/MEDICAL PROTOCOL BY THE INVESTIGATOR/PRINCIPAL INVESTIGATOR | 7. ASSESSMENT OF CAUSAL RELATIONSHIP BETWEEN THE SAE AND STUDY PRODUCT/MEDICAL PROTOCOL BY THE INVESTIGATOR/PRINCIPAL INVESTIGATOR | 7. ASSESSMENT OF CAUSAL RELATIONSHIP BETWEEN THE SAE AND STUDY PRODUCT/MEDICAL PROTOCOL BY THE INVESTIGATOR/PRINCIPAL INVESTIGATOR | 7. ASSESSMENT OF CAUSAL RELATIONSHIP BETWEEN THE SAE AND STUDY PRODUCT/MEDICAL PROTOCOL BY THE INVESTIGATOR/PRINCIPAL INVESTIGATOR | 7. ASSESSMENT OF CAUSAL RELATIONSHIP BETWEEN THE SAE AND STUDY PRODUCT/MEDICAL PROTOCOL BY THE INVESTIGATOR/PRINCIPAL INVESTIGATOR | 7. ASSESSMENT OF CAUSAL RELATIONSHIP BETWEEN THE SAE AND STUDY PRODUCT/MEDICAL PROTOCOL BY THE INVESTIGATOR/PRINCIPAL INVESTIGATOR | 7. ASSESSMENT OF CAUSAL RELATIONSHIP BETWEEN THE SAE AND STUDY PRODUCT/MEDICAL PROTOCOL BY THE INVESTIGATOR/PRINCIPAL INVESTIGATOR | 7. ASSESSMENT OF CAUSAL RELATIONSHIP BETWEEN THE SAE AND STUDY PRODUCT/MEDICAL PROTOCOL BY THE INVESTIGATOR/PRINCIPAL INVESTIGATOR | 7. ASSESSMENT OF CAUSAL RELATIONSHIP BETWEEN THE SAE AND STUDY PRODUCT/MEDICAL PROTOCOL BY THE INVESTIGATOR/PRINCIPAL INVESTIGATOR | 7. ASSESSMENT OF CAUSAL RELATIONSHIP BETWEEN THE SAE AND STUDY PRODUCT/MEDICAL PROTOCOL BY THE INVESTIGATOR/PRINCIPAL INVESTIGATOR | 7. ASSESSMENT OF CAUSAL RELATIONSHIP BETWEEN THE SAE AND STUDY PRODUCT/MEDICAL PROTOCOL BY THE INVESTIGATOR/PRINCIPAL INVESTIGATOR | ||||||||||||||||||||||||||||
No. (b) | Assessment of causal relationship between the SAE and study product/medical protocol | Assessment of causal relationship between the SAE and study product/medical protocol | Assessment of causal relationship between the SAE and study product/medical protocol | Assessment of causal relationship between the SAE and study product/medical protocol | Assessment of causal relationship between the SAE and study product/medical protocol | Assessment of causal relationship between the SAE and study product/medical protocol | If such relationship is available, would it be predicted or unexpected? ( c ) | If such relationship is available, would it be predicted or unexpected? ( c ) | If such relationship is available, would it be predicted or unexpected? ( c ) | If such relationship is available, would it be predicted or unexpected? ( c ) | If such relationship is available, would it be predicted or unexpected? ( c ) | ||||||||||||||||||||||||||||
| May be related | May be related | Not related | Not related | No conclusion | No conclusion | Predicted | Predicted | Predicted | Unexpected | Unexpected | ||||||||||||||||||||||||||||
i | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | ||||||||||||||||||||||||||||
ii | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | ||||||||||||||||||||||||||||
iii | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | ||||||||||||||||||||||||||||
iv | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | ||||||||||||||||||||||||||||
v | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | ||||||||||||||||||||||||||||
vi | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | ||||||||||||||||||||||||||||
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(b) The No. stated as specified in section 4
( c) The predicted or unexpected SAE shall be judged upon consideration of documents related to the study product/medical protocol such as the latest trial protocol (in case the study product is not granted the certificate of free sale) or the latest version of the user manual (if such study product is granted a certificate of free sale).
8. OPINIONS FROM REPRESENTATIVE OF THE ETHICS COMMIITEE/SCIENCE COMMITTE OF THE ORGANIZATION CONDUCTING CLINICAL TRIAL (if any) |
Proposal of trial participant (not applicable in case such participant is dead):
□ Continued participation | □ Participation suspension | □ Participation leave |
Proposal of clinical trial: |
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□ Continued trial | □ Temporary suspension | □ Permanent suspension |
Other proposals (if any): .....................................................................................
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9. REPORT PREPARER (principal investigator or authorized investigator) |
Signature | ................................................................................................. |
Sign date (dd/mm/yy) | ................................................................................................. |
Full name | ................................................................................................. |
Job position (department/division) | ................................................................................................. |
Tel | ................................................................................................. |
Email address | ................................................................................................. |
REPRESENTATIVE OF ETHICS COMMITTEE/SCIENCE COMMITTEE | HEAD OF ORGANIZATION CONDUCTING CLINICAL TRIAL |
(d) Only applicable if opinions are given in section 8.