No, although FDA encourages sponsors to obtain written
commitments from investigators, such commitments may not be required
or may even be prohibited in some countries, and FDA does not want to
preclude submission of well-designed and ethically conducted foreign
clinical studies solely because a written commitment was not obtained.41
To meet the requirement in 21 CFR 312.120(b)(11), sponsors or applicants
must submit a statement indicating whether written commitments by
investigators to comply with GCP and the protocol were obtained and, if
so, to maintain such commitments on file to be provided upon the
Agency’s request.For those sponsors following ICH E3 and E6, these
documents would be either submitted with the CSR or kept on file with
the sponsor or applicant.
