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.

Reader questions may have been edited for spelling or grammar, for reasons of anonymity, truncated, or edited in other ways although the main content remains unchanged.

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About The Author

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 [email protected] anytime.


  • Anonymous

    August 29, 2012

    How can we get meta data “Rave” training if we dont work in the industry?

  • The Lead CRA

    The Lead CRA

    February 2, 2012

    Soichiro, thanks for a great question. I agree it is a good blog topic. You rightly point out that some clinical data we capture in clinical trial databases are not captured in a normal clinical chart or outpatient card. I have worked on trials with electronic medical records, and trials with electric diaries or other electronic data capture instruments, but I don’t have experience working on a trial were the EDC system itself was source. I would insist on original source rather than accepting a screenshot. If the site did not want to provide source I would have them document this electronic procedure in a file not and I would have my company Quality Assurance team and the Project Manager review.

  • Soichiro

    January 25, 2012

    I love your blog!
    I can learn some practical tips and global standard practice on the blog. In addition, it is useful for learining english for clinical trial.

    I have a question regarding source document and I believe it is a good topic for the blog.

    Some page on EDC needs doctor’s diagnosis or judgement.(e.g. relationship between AE and IMP, reason for use of concomitant medication)But they aren’t written on medical chart in common. So we used to ask them to write it on the workbook or other record specified for study as source document.Is it an typical procedure in U.S as well?
    I believe it might be OK to enter some data into EDC directly. In this situation, original data is EDC data and source document is electric. Hence they should print the EDC screen out immediately and sign on it as certified copies and retain it for SDV. How do you think about it?

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