WHO: GOOD DATA AND RECORD MANAGEMENT PRACTICES

Some good stuff in this guidance….particularly the bit on True copies…..

GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES (SEPTEMBER 2015) DRAFT FOR COMMENT

True copy: A true copy is a copy of an original recording of data that has been certified to confirm it is an exact and complete copy that preserves the entire content and meaning of the original record, including in the case of electronic data, all metadata and the original record format as appropriate.

Full Guidance:  http://www.who.int/medicines/areas/quality_safety/quality_assurance/Guidance-on-good-data-management-practices_QAS15-624_16092015.pdf

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New Draft EMEA Paper on Electronic Source Data

Source data, the original entry for data in research or manufacturing, is expected to contain certain elements of Quality in the Pharma industry. These elements are often expressed with the acronym ALCOA (i.e., Attributable, Legible, Contemporaneous, Original, and Accurate).

When the data is in electronic format, the logistics of this change somewhat, and more guidance/clarification is typically needed. The Food and Drug Administration, FDA, has ruled on electronic data as source for clinical trials in the past.

Now the EMEA, the EU’s regulatory authority has published a draft paper outlining their expectations as to the use of electronic source in Clinical Trials. They have requested comments from industry stakeholders, experts, etc. by this April.

I have worked extensively in evaluating electronic data issues, especially in how they relate to clinical research, so I am very interested to see how  how EMEA’s position varies from FDA’s. I will be reviewing this paper thoroughly and time permitting, I may include a summary here.
~TJK