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4.1 Medical care of trial subjects
The investigator is responsible for adequate and safe medical care (or dental care, where appropriate) of subjects … +
4.10 Serious adverse events/reactions
The investigator must take appropriate measures to ensure the safety of clinical trial subjects (see also Sectio… +
4.11 Financing
The relationship between the investigator and the sponsor in matters such as financial support, fees, honorarium payments in kind must … +
4.12 Monitoring, auditing and inspection
The investigator must be prepared to receive and be available for periodic visits by the monitor(s) and accep… +
4.12 Monitoring, auditing and inspection
The investigator must be prepared to receive and be available for periodic visits by the monitor(s) and accep… +
4.12 Monitoring, auditing and inspection
The investigator must be prepared to receive and be available for periodic visits by the monitor(s) and accep… +
4.15 Termination of trial
In the case of premature termination of the clinical trial, the investigator must inform the drug regulatory authority, the … +
4.16 Final report
After completion of the trial, a final report must be drawn up and submitted to the drug regulatory authority. The report should be … +
4.17 Trials in which the investigator is the sponsor
In clinical trials in which the investigator is the sponsor, he or she is responsible for the cor… +
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4.1Safeguard Blinding in Data Governance
4.1.1 Maintaining the integrity of the blinding is important in particular in the design of systems, manageme… +
4.2 Data Life Cycle Elements
Procedures should be in place to cover the full data life cycle.
4.2.1 Data Capture
(a) When data captured on paper or… +
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4.2 Qualifications
The investigator should:
· have qualifications and competence in accordance with local laws and regulations as evidenced by an up-t… +
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EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2 +
4.2. Responsibilities
Roles and responsibilities in clinical trials should be clearly defined. The responsibility for the conduct of clinical trials … +
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4.2.3 Review of Data and Metadata
Procedures for review of trial-specific data, audit trails and other relevant metadata should be in place. It should… +
4.3 Computerised Systems
As described in sections 2 and 3, the responsibilities of the sponsor, investigator and the activities of other parties with… +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 4.3 +
4.3 Expedited AE (i.e., SAE) Reporting Timelines
Appendices 1 and 2 detail the expedited reporting requirements for AEs that occur on trials utilizin… +
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4.3 Selection of trial subjects
The investigator is responsible for ensuring the unbiased selection and an adequate number of suitable subjects accord… +
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EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 4.3 +
4.3. Inspection cooperation
• Cooperation between the EU/EEA MSs:
Nearly all the inspections conducted in 2022 were joint inspections involving inspe… +
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4.3.3 Security
(a) The security of the trial data and records should be managed throughout the data life cycle.
(b) The responsible party should ens… +
4.3.3.1 Investigations in pregnant women
Investigation of drugs that may be used in pregnancy is important. Where pregnant women volunteer to be enrol… +
