Lead CRA Q&A: Consenting Subjects Before IMP is On-site

properly consent subjects before dispensing investigational new drug

Are we ready for Consenting Subjects?

Anonymous commented in…

Pre-Study Visits and Site Initiation Visits“: November 26, 2010

Post SIV, can a site share the Informed Consent Form (ICF) with pre-identified subjects prior to Investigational Medicinal Product (IMP) receipt at the site?

The Lead CRA responds on consenting subjects…

Hi and thanks for your question. In one of my previous trials, all of our sites consented subjects and screened subjects prior to receipt of Investigational Product. First shipment was only triggered after a second qualifying screening visit (4 week screening window with up to 40% screen failure rate). Investigational Medicinal Product can only be released to a site once all of the required regulatory paperwork is in place. In order to begin consenting subjects, our SOP required that the site be authorized for drug shipment, rather than requiring that drug was actually physically on site. In order to authorize drug shipment the site must have 1) completed the SIV 2) received IRB approval for protocol, ICF, Investigator’s Brochure (IB), and all PRO instruments 3) Submitted complete regulatory document package to sponsor (1572, signed/dated w/i 1 year CVs for all personnel on 1572, Financial disclosures, Protocol signature page, IB signature page, etc. (some of this package goes to the FDA before the trial is initiated at the site) 4) fully executed contract and budget 5) written activation letter from sponsor. At that point the sites were allowed to begin distributing ICFs for review and signature from consenting subjects.

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The Lead CRA

Nadia started The Lead CRA blog in 2007. She is now lead author for ClinOps Toolkit. Nadia is currently working as a Clinical Program Manager at a small specialty pharmaceutical company in the San Francisco Bay Area. You can reach Nadia via email at leadcra@clinopstoolkit.com anytime.