Lead CRA Q&A: Sponsor Furnished Source Documents

Source Documents in clinical trials

Anonymous commented in… Perfect Clinical Trial Source Documents“:
Hi, some sponsors don’t allow investigators to use source documents in clinical trials such as data worksheets/templates arguing that source data should not contain instructions nor any other items (logo, etc.) which would not usually appear on a patient medical file.  Is there any legislation which confirms this audit finding? -April 7, 2011 3:18 AM

The Lead CRA responds…

source documents in clinical trials
Every required piece of
data isn’t already
in the medical file?

It would be great if the medical file captured everything we needed for every trial.  However, the reality is that sometimes source documents in clinical trials are required to capture supplemental information or observations that are above and beyond what would customarily be collected in the course of standard of care medical practice. For example, a patient Quality of Life survey, dosing and administration information, or PK lab draws.

Honestly the hesitation to provide source documents in clinical trials with logos might be more of an intellectual property thing rather than a regulatory thing. I know when I worked at CROs we were very careful not to include sponsor branding or logos on the outside of binders or in papers that were in view. We opted instead to reference by study nickname or protocol number. When I monitor, if I see source documents for another sponsor (maybe a competitor) I can discover confidential information and learn about another drug development program; that is extremely proprietary. Many public and private companies have to defend their product rights in patent legislation so it is important to eliminate logos and branding just to protect property rights.
Let’s assume however, that these confidentiality concerns are not the reason sponsors don’t allow source docs to have instructions, other items, or logos. I have worked for many sponsors that are careful to limit instructions given outside of the protocol to sites. That actually includes CRF completion guidelines, worksheets, and source documents. As sponsors, we have an obligation to produce a protocol that is clear and has scientific merit while protecting subject rights and safety. Some other responsibilities include choosing qualified investigators, providing adequate monitoring, etc. but the regulations in no way require us to provide source documents. This is a gray area and some sponsors feel strongly that they should avoid actions not explicitly delegated as a sponsor responsibility because that introduces risk. Some sponsors do not want to provide source documents at all, let alone source documents with their logos and emblems dotted throughout.
Allow me clarify with an example. If I generate source documents with blanks provided for all of the assessments required at a study visit but I leave one off (or worse, I include extra assessments) then that is in a way instructing the site personnel to deviate from the approved protocol. This is a huge no no because any changes to the protocol should be handled in an approved protocol amendment that is reviewed by an independent IRB. In operations, we face these issues all the time where we want to give sites instructions or clarifications that are outside of the protocol. If the instructions affect patient safety or the integrity of the trial we should always amend the protocol.
So to recap, I’m not aware of any regulations that prohibit sponsors from providing source documents in clinical trials and templates or even including their logos on source documents.  I am aware that some sponsors prefer not to provide source documents or to have their logos on the source for either confidentiality reasons or risk-mitigation reasons. To clarify further, sometimes we provide source documents because we are capturing something for a trial that would not otherwise be captured in the regular medical file. Hopefully that addresses your question. Otherwise, to further research the topic, I can refer you to ICH GCP E6 sections 1.51 and 1.52. Although “source documents” are not explicitly discussed in the regulations, FDA’s CFR 312.62(b) you can read more in the relevant section “case histories”.

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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 leadcra@clinopstoolkit.com anytime.