We plan to use an electronic Patient Reported Outcome (ePRO). Do we need to submit screenshots of ePRO to the Ethics Committee (EC)?
Swapnil Rameshwar
ICH GCP requires that the EC reviews all participant-facing materials. The primary concern of the EC should be to review the content of any evaluation instruments and questionnaires to make sure there is nothing promotional or unduly influential about the trial or the investigational product, and that any risks that may be associated with the electronic instruments are recognized and minimized.
The EC would expect the investigator to submit the non-electronic format (e.g., word file) for review and approval. Changing the format of the document to electronic form is unlikely to change these risks. Hence, submitting screenshots when the ePRO content has been reviewed and approved by EC would not add any real benefit.
If a patient withdraws consent in a clinical study, can the study coordinator/site contact the patient to return study drug to the site?
Dr Durgesh Deshpande
ICH GCP mandates
4.6 Investigational product(s)
4.6.1 Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution.
Regulatory authorities expect that every effort should be made to have the participant return the investigational product (IP). If the IP is not returned, documentation of such efforts to have the IP returned is important. Sponsors and investigators should have internal SOPs in place to address this issue. It is appropriate for the site/sponsor to call or email or contact the participant that has withdrawn from a study to obtain the unused IP.
We plan to use an outside phlebotomist for blood sampling for a study. Do we need to add phlebotomist’s details on the delegation log?
Dr Murli Mohan
The delegation log should include anyone who has an essential role in the conduct of the study. Whether or not the phlebotomists should be included depends on the requirements of the study. If blood draws are essential to either the timing, dosage, or follow-up of study participants, the identity of the phlebotomists assigned to the study would be important to capture. If the phlebotomists are rotating throughout the study, it would be important to list the lab on the delegation log.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com |