Do we need EC approval for written communication e.g. appointment reminders, thank you letters, newsletters, results notifications?
Christine Fernandez

In deciding which written communications require EC review and approval prior to use, the EC should consider whether such communications would be relevant for protecting the rights and welfare of the subject. Written communications that clearly have no effect on the conduct of the research, its underlying science or methodology, associated risks and benefits, or the potential willingness of subjects to continue participation would not require prior review and approval by the EC.

Based on these criteria, it would seem that simple appointment reminders and thank you letters would not require EC review and approval prior to use, provided no new information is included.

However, a thank you letter that included information on study results (new information) or solicited interest in another study would require EC review and approval prior to use. Additionally, written communications providing results notifications would also require EC review and approval prior to use. Because newsletters could potentially cover a wide range of topics, the specific content the newsletter is intended to cover would need to be considered in determining whether EC review and approval are needed.

If a subject signed an informed consent, but forgot to date his signature or wrote an incorrect date, what should be done?
Priti Pandit
If the subject wrote an incorrect date, he can be requested to cross out the incorrect date, enter correct date, initial and date the change. Additionally, the investigator could ask the subject to write a note explaining the error for inclusion in the subject's file. If the EC objects to having such a note written on the original consent form, then the site could use a coversheet or separate piece of paper that could be attached to the consent form with the explanation and the subject's signature.

If the problem is not discovered immediately, a note-to-file by the PI would be one way to document that informed consent was obtained prior to the subject participating in the study. However, it would not be ethical to ask the subject, who comes back at a later date, date the consent form with the date it was signed. Such a practice would be legally questionable and would not fully document what occurred. It would be better  to request the subject to document what  actually occurred, such as by signing and dating a statement that he/she signed the consent form on the date in question but did not date it.

Is it essential to re-consent all patients in a clinical trial, if there is a protocol amendment?
Srikumar Chaudhuri
If there is a protocol amendment, the subjects who are presently enrolled and actively participating in the study should be informed of the change if it might relate to the subjects' willingness to continue their participation in the study.  If the subjects have completed their active participation in the study, then re-consent is not required. If the change will be implemented only for subsequently enrolled subjects, or if the subjects are still actively participating when the change will not affect their participation, re-consent is not required.

Can a template of informed consent process be used to document the process in source notes?
Vishal Kulkarni
The informed consent process could be documented in the source notes by the use of a template. This method is not a violation of regulations. However, it is the responsibility of the investigator to customize and personalize this information according to each participant's needs and situation when informed consent is being given. This personalized information, when needed or necessary, should be documented.

Is it acceptable to keep scanned signed consent documents as the original consent as opposed to keeping the paper forms?
Dr Prakash Parikh
Signed informed consent forms are critical essential documents to be maintained by the investigator. The regulations require that investigators maintain in their records the signed and dated consent forms. The regulatory inspectors would like to review the original informed consent documents. Additionally, without the actual consent forms, there would be questions whether subjects signed the appropriate consent form.

Similarly the original source documents should be available for regulatory inspection to verify their authenticity, even if the copies in the site files are certified as authentic copies.  Hence, it is desirable for the investigator to keep original copies of all essential documents.