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re: Source Data Worksheets

By Liz Wool posted 03-11-2009 11:15 AM

  
I have managed clinical trials for Sponsor companies and utilized Source Data Worksheets successfully (FDA audited the study at both the sponsor level and the site level).

Key points as follows:
  1. Always have room for 'comments' on each form vs only a checkbox. The source data worksheet needs to also mimic medical practice whereby the practitioner would 'write notes' about the findings, patient etc. If the source data worksheets are 'only' checkboxes, then it can read as 'focusing on only the protocol data' and not the holistic approach to the patient's medical condition and medical care.
  2. Signature and date line for each page - 'this maps' to medical record charting practice.
  3. Maintain version control on these documents.
  4. Train staff to proper use and document the training
  5. The FDA regulations, ICH E-6 GCP (which the FDA has issued as guidance document) require us to keep case histories - and the details are explained very well in FDA Information Sheets for Investigators and ICH E-6 GCP Definitions and the Investigator Responsibilities Section.
Good Work in seeking help from your peers.

Liz Wool
President, Northern California Chapter ACRP
3 comments
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Comments

Liz Wool
03-10-2012 06:40 PM

Thanks Sandra. However, some therapeutic agents do not require the extensive documentation for medical practice. An example is a cardiac imaging agent - that II used the above noted methodology successfully as a clinical trial manager. The standard of care for managing cardiac echo patients did not require the extensive assessments and documentation required by the protocol. I concur that the patient's medical record is the source data per the standard of care.

Sandra Williams
03-10-2012 05:56 PM

That is correct due to the complexity of clinical trials today Source Data Worksheets are acceptable as source as long as the original source is on file in the chart or EMR.

Sandra Williams
03-10-2012 05:56 PM

That is correct due to the complexity of clinical trials today Source Data Worksheets are acceptable as source as long as the original source is on file in the chart or EMR.