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Documents (besides the protocol and Investigator Brochure) that are not distributed to patients and are not source documents need not to be submitted to JPEC as JPEC do not review documents those documents. However, the applicant is still allowed to submit a copy of those documents (i.e JPEC acknowledges the submission) but an approval will not be issued as it did not undergo a...

Some of the common conditions for approval for approval not met are: i) ICF does not contain the applicable requirements according to the Applicant’s checklist of minimum requirements in the informed consent form and written subject information. ii) Doctor’s name advertised in patient recruitment advertisements and materials iii) Incomplete document submitted (i.e no indemnity letter) iv) The coverage of medical fees through healthcare insurance provider...

For a single protocol with multiple sites, only one application form is needed for the initial application and also application for amendment and need to be signed by the Corresponding PI. For addition of sites to an already approved protocol, a copy of the Principal Investigator’s CV, Annual Practicing Certificate and GCP certificate would need to be submitted along with the site specific documents....

A simplified dossier is similar to that of the full dossier except the simplified dossier would not need to include the following documents: Investigator Brochure Insurance Policy Application Form...