Can the site keep scanned signed consent documents as the 'original' consent as opposed to having to keep the paper forms?
Dr Mukesh Agarwal
As per ICH GCP signed informed consent forms as essential documents to be maintained by the investigator. If there is an inspection at the site, the regulatory inspector would like to review the original informed consent documents. If the actual consent forms are not available, there would be regulatory questions about whether subjects signed the appropriate consent form, especially if there were revisions made to the form during a study.
During the monitoring it was noticed that the contact info on the ICF (whom to contact about questions on the trial) kept in the trial subject was missing. Is it acceptable to inform patient the correct contact info by telephone and record all correspondence?
Sandhya Kelkar
The contact info is an essential element of informed consent under GCP. If required information is missing from the copy of the ICF, the subject received and/or signed, it is essential to provide the subject with a revised copy of the entire consent document, with the additional information highlighted. Also, there should be a note to the file describing the error and the steps taken to rectify it.
In a clinical study in cataract patients, one subject’s LAR has signed, Is this acceptable?
Ashish Mitra
The subject with cataract would be visually impaired. Hence, he/she may not be able to read the consent documents. However, visual impairment would not render an individual incapable of providing his/her own consent. In such a case, the consent process should be done in presence of an impartial witness. If the subject is unable to sign, this information should be recorded in the case history/source notes, and a thumb impression could be obtained from the subject, in lieu of the signature.
Do CRF and Patient Reported Outcome (PRO) instrument require EC approval?
Jaydeep Gandhi
The EC should have all relevant information as to how the proposed clinical trial will be conducted. CRFs and PROs are essential supplements for the study protocol. The EC will want to verify that the CRFs accurately capture the protocol-required information. An EC will like to review proposed study PROs to determine their appropriateness for the particular study as well as for the study subjects. CRFs and PROs for a study are essential information for EC review and they should be approved as part of study approval.
For reporting of SAEs, whose judgment of causality is considered by US FDA?
Dr Anupama Subrahmanyam
As per US FDA requirements, the investigator is required to report SAEs along with an assessment of causality. The sponsor is required to report serious and unexpected suspected adverse reactions (SUSAR) to FDA and all participating investigators.
It is the sponsor’s responsibility to determines whether an event represents a SUSAR. The sponsor should take the investigator's assessment into account when determining if an event qualifies for reporting. However, sponsors should not report SAEs for which the sponsor assesses that there is no causal relationship between the drug and the event, regardless of the investigator's assessment of causality.
What should be covered in EC minutes?
Sarita Nene
As per FDA regulations, The minutes should be in sufficient detail to show
• attendance at the meetings;
• actions taken by the IRB;
• the vote on these actions including the number of members voting for, against, and abstaining;
• the basis for requiring changes in or disapproving research; and
• a written summary of the discussion of controverted issues and their resolution.
Dr Arun Bhatt is currently, president, ClinInvent, Research Pvt Ltd,
Mumbai. Readers can send their queries at: arunbhatt@clininvent.com