IDEs and Clinical Investigators - Advice About Records?

What to do with site files when PI physically closes site and moves out of state mid study?

  • Site should de-identify records and ship to the Sponsor (international).

    Votes: 0 0.0%
  • Find an Iron Mountain by investigator's site and keep them in the state, and away from Sponsor.

    Votes: 0 0.0%
  • Try to identify another MD familiar with research who will keep them.

    Votes: 0 0.0%
  • Something else - please suggest - no CRO involved.

    Votes: 0 0.0%
  • Do I need to re-consent all of the subjects?

    Votes: 0 0.0%

  • Total voters
    0
#1
Hello

I've been running an international IDE study for about 2 years. I'm the clinical lead. Trial involves subjects being treated with SBRT radiation with imaging timepoints at baseline, just prior to radiation, one after several weeks of radiation treatment, and final at 6 months past last radiation (about 8-9 months altogether).

One of my principal investigators (PI) just informed me that he's moving to a different state in the US. I told him to cease enrollment, and we're looking into whether any subjects will miss their 6 month imaging session (required by study, but not by standard of care). PI will inform the IRB. He's physically closing his practice, and there are no co-investigators.

My question is this: what do we do with the clinical study records, source data, and essential documents? I was told by our experienced regulatory person that they can't cross state lines (???) We've been monitoring 100% SDV the whole time. But, the site will close, so the records can't stay there. Do we inform PI to ship them to our company for storage? That seems weird to me. The records may not all be de-identified - we can ask them to do that. We're submitting to FDA in another year or so.

This hasn't come up in my 20+ years of research. Any advice gladly received - thanks.
 
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indubioush

Quite Involved in Discussions
#2
Aren't the clinical study records already de-identified? Don't copies of them already go back to you for clinical data entry? I don't know what SDV means when you say you have been monitoring 100% SDV.

What is the PI doing with all of the other medical records in his care that are not related to your study? Seem like this might be a shared responsibility; however, you should have all copies of your clinical study records.
 

Watchcat

Trusted Information Resource
#3
From 21 CFR 812.140:

(d) Retention period. An investigator or sponsor shall maintain the records required by this subpart during the investigation and for a period of 2 years after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application, a notice of completion of a product development protocol, a humanitarian device exemption application, a premarket notification submission, or a request for De Novo classification.

(e) Records custody. An investigator or sponsor may withdraw from the responsibility to maintain records for the period required in paragraph (d) of this section and transfer custody of the records to any other person who will accept responsibility for them under this part, including the requirements of §812.145. Notice of a transfer shall be given to FDA not later than 10 working days after transfer occurs.

This is from the regulations. FDA also issues guidances and information sheets that have additional information, but I've never heard of any prohibition regarding records being transferred across state lines, nor can I think of any reason FDA would have a problem with this.

The opinion of an "experienced regulatory person" who doesn't have a reference to back up their opinion has the same value as the opinion of an experienced plumber. The best opinion is FDA's own. You didn't say who holds the IDE. The IDE holder can contact the reviewing division.

However under the IDE regulations, the responsibility for the investigator's records lies with the investigator, so you might do well to contact FDA yourself:

Contact Us – Division of Industry and Consumer Education (DICE)
Bioresearch Monitoring Program Information

I would send an email explaining the situation, rather than trying to explain it over the phone. This is likely to be clearer and more convenient for FDA, and the response will give you documentation of FDA's advice.

Whatever you decide to do, I recommend that the IDE holder submit an information amendment to the IDE indicating where the records may be found in the event that FDA decides to inspect the study.
 
#4
Aren't the clinical study records already de-identified? Don't copies of them already go back to you for clinical data entry? I don't know what SDV means when you say you have been monitoring 100% SDV.
we're going onsite to monitor the essential documents binder protocol versions, correspondence, ICF versions) and subject binders. That's part of the job. We are doing remote source data verification of every data point by having the site either provide a certified, de-identified copy of wherever that data is first recorded, or allowing us to zoom with the study coordinators and then they show the subject data in Epic. Hoping this makes sense - it's the binders that are the issue here. Imaging and metadata are also source.
What is the PI doing with all of the other medical records in his care that are not related to your study? Seem like this might be a shared responsibility; however, you should have all copies of your clinical study records.
.
Typically all of the original records stay at the sites until 2 years after submission of data to the Agency (to permit onsite inspections). I was taught (clinical) that FDA doesn't want sponsor to have sole copy of site data until 2 years after submission. So, just not sure what a good citizen is to do?

Should the practice hire a replacement MD in the specialty area, that might be a way forward. It's a good idea to ask about his other patients.

Thanks so much for your response!
 
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