Electronic Medical Records and Source Data for Research: What s the Difference?

Transcription

1 Electronic Medical Records and Source Data for Research: What s the Difference? Tammy Anderson, CCRC, CCRA, CRCP Director, Clinical Trials Office Virginia Commonwealth University Research Coordinator 4 th Friday Lunch and Learn June 25, 2010

2 Objectives To discuss the difference between source of data, source data and source documents To review regulatory requirements specific to source documentation To identify the FDA requirements and expectations when conducting site audits To share best practice procedures that can be used to fulfill audit expectations 2

3 To Be or Not To Be? Relied on to perform regulated activities Electronic Medical Records Paper medical records (charts) Hybrid system (combination of electronic and paper records) Napkin you wrote AE note on Your left hand you wrote BP results on 3

4 Source of Data: Part 11 Relied on to perform regulated activities Defines what is considered your location of original source documentation for the purpose of FDA reporting as electronic or paper. 4

5 Source Data: GCP 1.51 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). 5

6 Source Documents: GCP 1.52 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.and records kept by departments involved in the trial. 6

7 PI Responsibility: CFR Case Histories Includes: Case report forms Supporting data for CRFs Signed and dated consent form Medical records Progress notes, nurses notes Documentation that consent was obtained prior to participation 7

8 PI Responsibility: GCP The Investigator should not implement any deviation from the protocol without agreement by the sponsor AND documented approval by the IRB the written informed consent form should be signed and personally dated by the subject. (Also CFR 50.27) 8

9 PI Responsibility: GCP CRF derived from source documents should be consistent or discrepancies explained The Investigator should take measures to prevent accidental or premature destruction of documents 9

10 You d Better Be FOI/ElectronicReadingRoom/ucm htm 10

11 Best Practices Sponsors and FDA should be told we use paper as our source of data, not EMR Anything in Cerner to be used as a source document should be printed and certified Certify the printed copy by using a stamp saying Original certified copy on each printed page, initial and date to make the copy certified and verified source data 11

12 Best Practices Print and certify all notes that verify history Place hand written progress note pages in each subject binder to document nursing and/or coordinator notes and any explanations for deviations or changes made File source documentation with visit CRF s or separated by visit tabs if using EDC so auditors don t have to search for them 12

13 Best Practices Add consent process documentation to source document worksheets or separate page to cover all CFR and GCP requirements Waivers are no longer accepted by FDA tell the sponsor no thanks if they offer one Plan on keeping records for years 13

14 Be the best! Documentation of source data with this level of detail and expectation that you will be FDA audited will result in: Cleaner data and easier monitoring Reduces overlooked AE and con med reporting FDA audits with no critical findings or 483 s 14

15 Questions Tammy Anderson