Skip to main content
. 2007 Jan-Mar;41(1):27–31. doi: 10.4103/0019-5413.30522

Table 3.

Subject folder

  • Protocol synopsis - It is a good idea to have a simplified version of the protocol that explains in simple and nontechnical terms the process and timeline the patient will need to adhere to during the duration of the study.

  • Medical release of Information for medical records.

  • Informed consent form (two signed copies – one for the subject and one for the research records).

  • Screening sheet that includes inclusion and exclusion criteria for determining eligibility.

  • Pertinent case report forms.

  • Laboratory, radiographic or other records associated with the study.

  • Compensation vouchers if the subjects are getting paid.

  • Letters or communication to or with the subject.

  • Other subject-specific documents as applicable.