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Diaries as Source Documents 发布时间:2016-05-24

Question 1:

It was wonderful to speak with you just now. Thank you so much again for taking time out of your day to give us some guidance on the topic of paper diaries as source documents. Below I will be summarizing our conversation. If you could confirm this information, and reply to my email to verify, I would greatly appreciate it.

- Paper diaries are considered source documents

- Per ICH guidelines, original source documents must be prepared and maintained by the Investigator.

- If the originals must be sent to the CRO / Pharmaceutical company, Certified copies must be maintained at the site.

"Certified" means that the document has been verified as complete and accurate, and has been signed and dated on every page (STAN - WHO NEEDS TO SIGN THE DOCUMENT?)

- In terms of document retention, a Sponsor is not as obligated to retain information as the PI would be. Therefore, the investigator should keep all original source documents at their site, if at all possible.

If I've missed anything, please advise.

Answer 1:

The regulations themselves do not explicitly define the term source document nor explicitly require the clinical investigator to retain source documents per se. The relevant regulatory requirement for the clinical investigator in an IND study is 21 CFR 312.62 (b) which requires the investigator to prepare and maintain adequate and accurate case histories. I believe that paper diaries completed by subjects to record their symptoms and reaction to a study drug would fit within the definition of a case history, therefore must legally be retained.

As to the question as to whether they are source documents one should refer to our official guidance on that topic which is the ICH E6 Consolidated guide on Good Clinical Practice found on the web at www.fda.gov/cder/guidance/959fnl.pdf.

Specifically the following terms are defined:

1.51 Source Data: All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).

1.52 Source Documents: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial).

As you can see subjects' diaries are specifically cited as examples of source documents. As you can also see, copies or transcriptions certified after verification as being accurate and complete are considered to be source documents. Likewise source data can include certified copies of original records. The term certified copy is not defined in the ICH E6 guidance,

however, we have attempted to define this term in our Guidance on Computerized system in Clinical Trials found at www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm .

In that guidance we have defined the term as follows; Certified Copy means a copy of original information that has been verified, as indicated by dated signature, as an exact copy having all of the same attributes and information as the original.

In response to your point below, it is not necessarily required to sign and date every single page to have a certified copy, although of course this is one approach. However, it may be acceptable to sign off on a whole case report form that has been verified against the copy. It depends upon how your SOPs are written and how the data is handled and its format (i.e. bound together, limited access, microfilm etc.)

The other points you raise about who should retain the source document where and when are best addressed in section 8 of the ICH guidance dealing with essential documents. Specifically section 8.3.13 recommends that source documents be retained at the clinical site during the trial section 8.3.14 recommends that Signed, dated, and completed case report forms be retained both at the site as a copy and also at the sponsor's as originals.

Finally regarding the regulatory requirements for Sponsor record retention requirements I would refer you to 312.57

Source from FCR

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