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Is it necessary for the sponsor’s clinical study manager to review 100% of monitoring visit reports in risk based monitoring approach?
Keyur Shroff
ICH GCP E6(R2) recommends that review of the monitoring report should be documented. The guideline uses the term “the”, which suggests that each monitoring report should be reviewed and documented. A sponsor can adopt risk-based monitoring approach and create a sampling plan for the review of monitoring reports. However, the sponsor should be able to justify this sampling approach and provide a rationale why it would not negatively impact the data integrity of the study and the safety of clinical trial participants. Although 100% review of monitoring reports is not a regulatory requirement, it is in the best interest of the sponsor to do so to ensure proper monitoring of the investigations. This will facilitate the sponsor to identify noncompliance and to promptly secure clinical investigator's compliance with the signed agreement, investigational plan, and the requirements of the applicable regulations and GCP guideline.
If a clinical trial participant has withdrawn informed consent and participation in a clinical trial, can the sponsor request the enrolling site to provide data/information about the trial participant?
Dr Madhuri Kulkarni
If a clinical trial participant withdraws informed consent from the interventional part of a trial and does not wish to continue follow-up of associated clinical outcome information, the investigator should not access the participant’s medical record or other confidential records requiring the participant’s consent for purposes related to the trial. However, an investigator may review study data related to the trial participant, which were collected prior to the participant’s withdrawal from the trial.
What are regulatory expectation for digitalization of paper-based source documents for clinical trial? Can we destroy paper copies after digitization?
Priyamvada Mehta
Regulatory agencies e.g., the US FDA and others, expect compliance to 21 CFR part 11 if the investigator site intends to use an electronic scanned copy in lieu of the paper source data. FDA would accept the electronic scanned copies of documents without the original paper records, if there is a standard operating procedure (SOP) in place to certify that the electronic copy is an exact representation of the original paper document. The person who certifies the copy as an exact and complete representation of the original, having all the same attributes and information, should be the same person who made the copy from the original. The person who makes the copy should sign or initial and date the copy to show it meets the requirements of a certified copy as required by regulations and GCP guideline. FDA allows the interchangeable use of electronic and paper records for the archiving and protection of records if record keeping and retention requirements follow relevant regulations.
The sponsor wants to include details of patient travel expenses in the clinical trial agreement but not in the informed consent document. Is this acceptable?
Dr Sreevatsa
Patient’s travel expenses/compensation for participation are part of informed consent document and need review and approval by the Ethics Committee (EC). The purpose is to (1) make the participant aware that they do not have to pay ant travel/other expenses for participation in the trial and (2) to obtain EC approval of the amount for this purpose.
Indian Regulations and guidelines include this in informed consent document.
• New Drugs and Clinical Trials Rules 2019 Table 3 (xi) The anticipated prorated payment, if any, to the subject for participating in the trial.
• ICMR Guidelines 2017 Box 5.1 7. Payment/reimbursement for participation and incidental expenses depending on the type of study.
Hence, these expenses should be described in the Patient Information Sheet.
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