One of our investigators wishes to transfer essential documents to sponsor. Is this acceptable?
Dr Supriya Shah
ICH E6 R2 Addendum 2016 mandates:
The sponsor and investigator /institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should provide for document identification, version history, search, and retrieval.
The sponsor should ensure that the investigator has control of and continuous access to the CRF data reported to the sponsor. The sponsor should not have exclusive control of those data.
The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.
Considering this new GCP amendment, the investigator should not transfer the essential documents to the sponsor.
In an ongoing study, the sponsor wants the site to send reminders – test messages/emails – to participants to encourage compliance to the study product. What process should the site follow?
Dr Durgesh Gandhi
As this is information for the participants, you should submit this information for ethics committee (EC) review. The EC should review the use of texting and e-mailing in this study and determine if it is an appropriate way to communicate to clinical trial participants, and approve if it meets ethical requirements.
As this text/email communication is part of the study information, the site should retain it. As such messages are likely to contain information pertinent to the study, the regulators would consider this information as study source documents rather than simply correspondence.
In an EC meeting, can alternate members be used for different members who are not present?
Dr Madhuri Jerajani
The use of formally appointed alternate EC members is acceptable, provided that the EC SOPs describe the appointment and roles and responsibilities of alternate members. The EC roster should identify the primary member for whom each alternate member may substitute. The alternate member's qualifications should be comparable to the primary member, to ensure that quorum requirements are fulfilled. The EC minutes should record when an alternate member replaces a primary member. When alternate member substitutes for a primary member, the alternate member should have received and reviewed the same material that the primary member received or would have received.
The alternate member can only substitute for a primary member fulfilling a specific role in the EC.
Does an EC need to provide oversight for ongoing post-trial assessments of study-related safety events?
Dr Usha Thorat
If the trial is completed and the data collection from all trial sites is complete, and the overall study results database has been locked, and the only remaining activity is statistical analysis of the data by the study sponsor, further continuing review of the research is generally no longer required. However, the EC SOP should describe the process for continuing review of research and describe when EC oversight is no longer required.
We intend to manufacture and sale a product with same label claims and excipients with same route of administration approved in India in 2004. Do we need CDSCO approval?
Yogesh Bhide
As per Drugs & Cosmetics Rule 122E a new drug shall continue to be considered as new drug for a period of four years from the date of its first approval.
As the product was approved in 2004 and there is no change in route/indication, it is not classified as a new drug. Hence, this product does not require DCGI approval.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com