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Is there any guidance regarding the acceptable and reasonable time frame for safety assessments of adverse events (AEs) such as laboratory values by an investigator?
Dr Indira Nadkarni
Regulatory authorities would expect review of safety information by the investigator is conducted in timely fashion. Although the term timely is not defined, regulatory authorities would expect that all study activities, including reviewing lab results, should be performed to protect the rights, safety, and welfare of research subjects.
It is advisable to include description of clinical procedures, laboratory tests, or other measures to be taken to monitor the effects of the drug in human participation. As all serious adverse events require immediate (24 hour reporting) to the regulatory authorities, ethics committee and the sponsor, it would be essential for the investor/site team to review all potential AEs within a time frame which allows the investigator to provide medical care to trial participant for any AEs including clinically significant laboratory values, related to the trial participation.
What is the best practice for managing e-mail communication between the sponsor team and the site?
Hitesh Shah
From regulatory agency view, e-mail is a reasonable and reliable method to send information because e-mail systems inherently meet requirements for electronic systems such CFR part 11.
E- mail systems, when used properly, have controls that ensure: 1) limited system access through individual user accounts/passwords, 2) the confidentiality of information contained in messages/attachments; and 3) user authentication.
The use of e-mail in place of correspondence is acceptable practice as it has adequate controls for the types of documents.
If an e-mail communication would have an impact upon the clinical trial conduct, then it would be essential to maintain a record of that communication and/or decision. A dated signature would only be needed if the document is a certified copy, which is probably not likely for an email.
Certified copy: A certified copy is a copy of original information that has been verified, as indicated by a dated signature, as an exact copy having all of the same attributes and information as the original.
Returning the e-mails to the site by burning them to a disk in PDF format is acceptable practice.
What action can the ethics committee (EC) take if the investigator does not comply with the condition of approval and regulations?
Dr Sreevatsa
The EC can stop the clinical trial and inform DCGI about the ethical and protocol violations.
See relevant NDCTR19 excerpt: Functions of Ethics Committee (v) where at any stage of a clinical trial, it comes to a conclusion that the trial is likely to compromise the right, safety or well being of the trial subject, the committee may order discontinuation or suspension of the clinical trial and the same shall be intimated to the head of the institution conducting clinical trial and the Central Licencing Authority.
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