TABLE 1

Minimal Document Requirement for Initial Review Application (Clinical Trial Site)

Cover letter
Application for new study
Addenda for biologic, drug, or device
Protocol
Investigator brochure
Research team agreement, disclosure, attestation form (investigators and coordinators)
Parental permission form
Informed consent (if participants are ≥18 y)
Adolescent assent
Child assent
Short form (if few non-English speakers expected) or professionally translated consents (if significant number of non-English speakers expected)a
Recruitment tools
Approvable flyersb
Web site social media postings
TV radio ads
Scripts for telephone recruitment
Outcome assessment tools (questionnaires, checklists)
Proof of radiation committee approval
Proof of human research protection training for all team members
Proof of biosafety committee approval
Letter of support from Department chair and institutional collaborators (core facilities, etc)
If applicable, merit review committee approval
Pharmacy approval
Curriculum vitae of investigator(s)
  • Some IRBs may require diaries and summary of the manual of operating procedures.

  • a Cost of translations can be negotiated with sponsor.

  • b Usually, dollar figures for participant incentives are not permitted.