essential_documentsSlow study start-up times are a major problem for Sponsors running clinical trials.  The last thing a site wants to do is contribute to this problem.  By ensuring you have the correct Essential Documents on hand, you can help your site be initiated quickly.

The full list of Essential Documents is available in section 8.2 of  the GCP document.  Some of these documents the site has control over and some they don’t.  Here is a list of those which you can control:

  • Investigator Brochure Acknowledgement of Receipt (8.2.1)
  • Protocol signature page (8.2.2)
  • HREC committee composition (8.2.8)
  • Signed, up-to-date CVs for all study staff (8.2.10)
  • GCP certificates for all study staff (8.2.10)
  • Reference ranges (preferably signed) for your local lab (8.2.11)
  • Local Lab accreditation (NATA can be downloaded from the NATA website) (8.2.12)
  • Obtain test or ‘phantom’ scans for review by central radiology (8.2.12)

Here is a list of documents that by speedy review you can assist with:

  • Customise the PICF to site requirements (8.2.3)
  • Give the Sponsor a list of your set fees (8.2.4)
  • Prepare and review the study budget (8.2.4)  (see this post for some tips). (8.2.4)
  • Provide the Sponsor with a pre-approved CTRA template (8.2.6)
  • Submit to HREC as soon as possible (8.2.7)

Be proactive and don’t wait to be prompted by the Sponsor.  Speedy start-up is good for everyone.

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