Considerations For Using Electronic Medical Records (EMR) In Clinical Trials
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1 Considerations For Using Electronic Medical Records (EMR) In Clinical Trials Combined CRCS-CRP Forum (Aug 2016) Alex Goh Regional Clinical Quality and Medical Quality GlaxoSmithKline
2 The views expressed in this presentation are my own and does not represent the views of GlaxoSmithKline. Slide No. 2
3 Evolution of the Clinical Trial Data Collection Paper Medical Records EMR Verification Paper CRF ecrf Clinical Database Slide No. 3
4 EMR Why the emphasis on EMR? Slide No. 4
5 Slide No. 5
6 Life Cycle Construction Database Reliability Accuracy Assuring Stability Records Corporate Transfers Consistency Flow Archiving Data Integrity Facts Maintaining Computing Indicators Institution Trustworthy Slide No. 6
7 Considerations for using EMR in clinical trials
8 1. Assessing the risks of EMR
9 Risks of using EMR in clinical trials Root causes: Complex and diverse data standards used by the institutions Varying EMR systems across institutions and countries Diverse ownership of data Inherent inter-operability issues in the EMR system Lapse in security controls and discipline by EMR users Unknown process of validation and maintenance of EMR Limited training on required standards of EMR Slide No. 9
10 2. Training on EMR required standards
11 Regulations and Standards Good Clinical Practice 21 CFR Part 11 Industry Guidance Laws Slide No. 11
12 GCP 5.5.3: Requirements for Computer Systems. Slide No. 12 ICH Harmonised Tripartite Guideline Guideline for Good Clinical Practice. pp21.
13 Slide No CFR Part 11
14 Part 11: Electronic Records and Electronic Signatures (1997) Technical and procedures requirements Industry s gold standard on principles of EMR System Slide No. 14 US Food and Drug Administration. Code of Federal Regulations Title 21. FDA. [Online]. Available: [Jul 2016].
15 Industry Guidance 1. Part 11, Electronic Records; Electronic Signatures Scope and Application (2003) 2. Computerized System Used In Clinical Investigations (2004) 3. Electronic Source Data in Clinical Investigations (2013) 4. Use of Electronic Health Record Data in Clinical Investigations Draft (2016) NEW Slide No. 15 US Food and Drug Administration. Code of Federal Regulations Title 21. FDA. [Online]. Available: [Jul 2016].
16 Laws Privacy Act Personal Data Protection Act Health Record Act Slide No. 16
17 3. Evaluating the EMR
18 Characteristics of EMR An Electronic Medical Record is: A computerised medical record created by a healthcare provider Serves as a Health Information System Electronic record that is created, stored, retrieved and modifiable Usually stand alone Access is controlled and requires login details Use of Electronic Signatures A Closed System Slide No. 18
19 Part 11 Electronic Records: Controls for Closed System Authenticity Data Integrity Confidentiality Slide No. 19
20 4. Alternatives to EMR
21 Decision on EMR PASS FAIL FAIL Slide No. 21
22 Creating Certified Hard Copies: Process A hospital SOP (or equivalent documentation) on: The need for maintaining hard copies of electronic documents The methods for certification of hard copies as true and complete copies of electronic documents Requirements for the certification process*: 1. Qualified individual 2. A signature of the individual making the photocopy/printing 3. The date the copy was made 4. A written statement attesting to the accuracy and completeness of the copy * These requirements must be traceable to all pages copied (e.g. Pg 1 20) CRAs should at least be able to view/review the study records in EMR to check for accuracy and completeness of the hard copies made Slide No. 22
23 Conclusions It is important to ensure data integrity and quality of clinical trials: Risk assessment of EMR Training on required standards Evaluation of the EMR Alternatives to EMR Slide No. 23
24 Thank You For questions, further discussions, contact:
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