I know I am a little late in joining the discussion. Upon completion of a trial, when the center file is complete, the PI usually signs an agreement with the sponsor of the trial to retain documents for a particular time. There are some sponsors which give a definite time frame which are in line with regulations but others will say until a notification is received from them, which is practically saying indefinity. Should a facility decide that they do not have enough room or in your case a facility is closing and the documents can not longer can be retained there meeting archiving requirements. Then this facility will need to contact the sponsor to discuss what other alternatives are. The sponsor must know at all times the location of these documents and also must ensure that where these documents are archived meets archiving requirements.
I have heard of many strange experiences of where some documents have ended, e.g. a physician stopped his practice and did not where to place the records. They were later found in his basement at home. His wife was using some of the pages as labels for her homemade jam.
The reason why the importance. The sponsor has a copy of certain records and the site has records, for simplicity say the CRF (case report form). Should one set be destroyed one still has a backup (copy), meaning valuable information has not been lost.
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Natalie Borde
Waalre
Netherlands
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Original Message:
Sent: 12-20-2011 14:11
From: Wajeeh Bajwa
Subject: Records from a clinical trails facility
I appreciate everyone's input and discussion on this topic. There are no samples that we are holding at this facility only the paper records.
Yours,
Wajeeh Bajwa
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Wajeeh Bajwa
Director Regulatory Knowledge and Research Support Program
United States
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Original Message:
Sent: 12-19-2011 15:23
From: Heimo Scheer
Subject: Records from a clinical trails facility
I need to be clearer here: my response below really only applies to sample retention of test article(s) in a BA/BE study, a very common activity in a Phase 1 center. As described under 21CFR320.38 and 21CFR320.64, the samples need to be retained by the CRO or a third party but should not be returned the sponsor under any circumstance. Transferability of the articles is described in a recent guidance http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126836.pdf as well as in http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm120265.htm
I apologize for any confusion. I will never again provide an entry on a Sunday night; odds are good I'd just mess something up again.
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Heimo Scheer PhD RAC
Vice President, Regulatory Affairs
Celerion
Somerville MA
United States
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Original Message:
Sent: 12-18-2011 17:35
From: Heimo Scheer
Subject: Records from a clinical trails facility
Agreed, but to the other question as to whether the documents can be returned to the sponsor, the answer would be: it depends. A pilot, non-pivotal study of some sort, yes, possibly; a pivotal study in support of, e.g., an ANDA approval on the other hand should not be returned to sponsor but really should go, as stated right below, to another CRO
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Heimo Scheer PhD RAC
Vice President, Regulatory Affairs
Celerion
Somerville MA
United States
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Original Message:
Sent: 12-16-2011 13:09
From: Siegfried Schmitt
Subject: Records from a clinical trails facility
Though you remain responsible for your trial records, you cna outsource the maintenance and archiving of these records to a CRO, who may have such systems and processes in place for many of their customers
Regards
Siegfried
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Siegfried Schmitt
Principal Consultant
PAREXEL
Braintree, Essex
United Kingdom
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Original Message:
Sent: 12-11-2011 11:59
From: Wajeeh Bajwa
Subject: Records from a clinical trails facility
We are in the process of closing one of our Phase I clinical trial sites. At this time we have roughly record of about 20 studies in our storage facility. Question is: Can we ask sponsors to take these records and be responsible for these records or are we suppose to keep these records even when this facility will no longer exist.
Any thoughts, suggestions, and pointers to the relevant regulations and guidance documents will be greatly appreciated.
Thank you.
Yours,
Wajeeh Bajwa
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Director Regulatory Knowledge and
Research Support Program
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