Protect Your Firm as FDA Inspections Spike for CROs, Sponsors

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During the last two years of my time with FDA I noticed the amount of Sponsor and CRO inspections triple in number (for CDER, CDRH, & CBER).  CRO’s with less than adequately trained clinic staff and facilities to conduct human clinical trials are receiving warning letters and other FDA regulatory penalties.  The FDA has not conducted enhanced Sponsor or CRO inspections in many years.  I have observed study sites get warning letters because monitors did not catch informed consent violations early in the trial or for other regulatory and subject record keeping violations.  Catching serious problems early in the trial can prevent adverse events, save time and assets in the long run.

Clinical Investigators and Sponsors  do not want to throw study data out due to preventable errors and inconsistent data.  Monitors for CRO’s and Sponsors should be proficient at the Quality Assurance (QA) they provide and be given adequate time at the study site to ensure regulatory and protocol compliance.

In my time at the FDA, even up to the end of my tenure this past March, I have observed CRO’s collecting original source site documentation from the clinic site at study close-out. I wonder how CRO’s seem to keep missing the basic reason FDA investigator’s conduct data-validation audits.  FDA wants to validate that source documentation match the case report form (CRF) and the sponsor provided data-listing with efficacy end points & adverse event lists.  CRO’s can easily scan the original documents into their system, but physically removing the source documents has conditions.

If a CRO truly wants the original documents for whatever reason, the CRO may certify each copy as a true duplicate of the original (21 CFR describes this process).  In many cases the Clinical Investigator relocates or there is no available space and money to store the records so the sponsor may step in to take over.  There’s not going to be any problem as  long as the FDA can follow the paper trail and review original documents as needed.   Copies may and have been found to be falsified so Investigators will not review paper copies of paper source records.  Electronic printout (output) is a different way to operate now and is acceptable for review.  Sponsors & CRO’s are using more electronic case report forms CRF’s & electronic records in general.  FDA is now requiring field Investigators to review computer systems for 21 CFR part 11 compliance & legacy system maintenance.

Do a search for your competitors’ recent FDA inspections and you will see the trend I am describing.  Build quality into your system from the ground up and you will get quality product results.  Trying to retroactively validate electronic systems and equipment or implement late stage corrections will leave you vulnerable to 483 observations.

Patrick Stone is President of TradeStone QA.


Showing 2 comments
  • Reply

    Wouldn’t it be advisable to generate data with paper-less system that is compliant to 21CFR11? So, data migration occures dynamically. I think, it will be cost effective at the end.

    • Reply

      I would definitely advise a start-up or established firms to migrate to 21 CFR part 11 compliant paper-less Case report forms & data capture systems. This migration serves two purposes which are functional web-link access to more QA reviewers & less travel. The other reason is for future applications like FDA or EMA reviewer real time access. This is not a function available to FDA however if you go all electronic it will be. Long run cost effectiveness is priceless. Trying to retrofit a non-compliant system is a triple cost issue. The worst case scenario is your establishment get a revealing 483 damaging the brand & loss of valuable assets.

      Thanks for your comment.

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