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In site less decentralized trials, what should be location of clinical trial conduct for regulatory purpose?
Dr Suneel Dange
As per the US FDA, for inspectional purposes, the address listed in Form 1572 should be the physical location where all trial-related records are accessible and where the investigator is located and trial personnel can be interviewed, either in-person or remotely. All information required under applicable regulations for investigational products to be maintained for trial participants should be accessible at this site.
Can a clinical investigator enroll her own child in a pediatric clinical trial?
Dr Subhashini Patil
Guidelines or regulations explicitly prohibit a clinical investigator from enrolling a family member in a clinical trial, provided that they meet the selection criteria described in the study protocol. However, both the sponsor and the Ethics Committee responsibility to oversee the recruitment of participants. So, they impose restrictions on whether an investigator’s child can participate in a trial because of potential ethical concerns. Enrollment of a family member raises the issue of potential coercion or undue influence by the investigator on the family member. Usually, the sponsor or Ethics Committee are likely to advise the investigator against recruitment of the family member because of potential challenges in ensuring compliance of informed consent procedure to regulations and guidelines and issues during conduct of clinical trial such as safety reports.
Is it acceptable if a clinical investigator types the subject visit information into a word document, sign and date printed copy?
Arvind Kapadia
Regulatory authorities e.g., the US FDA, accept as source data, participant visit information drafted and printed on a computer if the computer is used for creating paper records that are subsequently maintained in a traditional paper-based system, and the paper-based system meets all the requirements of the applicable regulations. However, if the participant visit information was transcribed into the computer from hand-written information, then the paper documents from which the data elements are transcribed are the source, and these paper data must be maintained by the clinical investigator as source data.
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