Does FDA expect the site to print copy of electronic data capture (EDC) form?
Dr Ramesh Kulkarni
FDA’s guidance on Computerized Systems Used in Clinical Investigations allows direct entry of data electronically onto a PC or laptop. The FDA investigator (inspector) is expected to be able to review electronic CRFs. However, the FDA investigator would request that someone at the site to access the data and provide paper copies for any page(s) requested, as the navigation of the site's computer system would be cumbersome for the FDA investigator.
FDA investigator would expect to check how the audit trails of all changes made to information in the electronic records are tracked and maintained. The use of audit trails helps to ensure that only authorized additions, deletions, or alterations of information in the electronic record have occurred and allows a means to reconstruct significant details about study conduct and source data collection necessary to verify the quality and integrity of data. Computer-generated, time-stamped audit trails or other security measures can also capture information related to the creation, modification, or deletion of electronic records and may be useful to ensure compliance with the appropriate regulation. Audit trails or other security methods used to capture electronic record activities should describe when, by whom, and the reason changes were made to the electronic record. Original information should not be obscured though the use of audit trails or other security measures used to capture electronic record activities.
If a patient withdraws informed consent in a clinical trial, can the site contact the patient to return study drug to the site?
Priyanka Maniar
The sponsor and the investigator have responsibility for accounting of investigational products for a clinical trial. During monitoring, audit, or inspection, these investigational products records are reviewed to check compliance with requirements for accounting for investigational products and compliance with the protocol/investigational plan. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. If the investigation is terminated, suspended, discontinued, or completed, the investigator should return the unused supplies of the drug to the sponsor. Hence, every effort should be made to have the clinical trial participant return the investigational products. If the product is not returned, the site should have documentation of the efforts to have the investigational products returned. It is appropriate for the site/sponsor to contact the participant who has withdrawn from a study to obtain the unused investigational products.
What would be issues for the investigator on recruiting family members for a clinical trial?
Dr Vinay Agarwal
There are no specific regulations that describe family volunteering to participate as study participants in a clinical trial. However, inclusion of a family member in a clinical trial could pose some challenges in the conduct of clinical trial. If a family member participates in the clinical trial as a participant, the investigator might find it difficult to personally conduct or supervise his/her participation including the treatment and reporting of unanticipated and serious adverse events). There is potential for introducing bias into the trial because the family member who enrolls as a participant may have access to information that other participants do not typically have access to e.g. safety or adverse event. Recruitment of family members to participate in the study may introduce an element of coercion into the consent process.
As a result, a second investigator would have to be selected by the sponsor to ensure that the trial was properly conducted throughout the entire study. The sponsor would be reluctant to do this because this could unnecessarily complicate the study. The ethics committee may out restrictions as would find it difficult for the investigator to properly supervise the conduct of the study while enrolling family as participants in the study.
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