I have a couple of questions regarding PID held within the archived TMF/ISF.

IRAS Q43 asks ‘How long will personal data be stored or accessed after the study has ended?’ A range of options are offered, from less than 3 months to over 3 years. If keeping longer than 3 years, IRAS asks the applicant to justify this.

However, PID/personal data is almost always contained within the archived TMF/ISF, eg, in consent forms, or within the list of trial subjects and their trial identifiers. Therefore, the answer to Q43 would almost always be over 3 yrs?

Also, is there any guidance offered as to what PID/personal data may be held within the ISF? Let’s take the example of participant payment receipts (where a pt signs to say they have been paid for attending a study visit). This could be deemed as an essential document; in that it permits evaluation of the conduct of a trial (payment could be deemed to be an important aspect of trial conduct). Therefore, would it be appropriate to hold such documents within an archived ISF?