1 Clinical and Translational Science Institute / CTSI at the University of California, San Francisco Update on Monitoring & Electronic Medical Records January 10, 2012 at UCSF Danusia Filipowski, MD Director, CRC-Core UCSF CTSI 415/
2 This discussion will include: Certified Medical Records Clinical i l Research & Medical Records in APEX
3 Let s begin by reviewing some definitions 1. Def: Source Documents Describes the types of records that we routinely find being used to document events that occur during the conduct of clinical trials. This includes: Original documents, data and records. EXAMPLES of some types of records: hospital records subjects' diaries memoranda Clinical and office charts evaluation checklists laboratory notes X-rays &Oth Other images pharmacy dispensing i recorded d data from records automated instruments reports copies or transcriptions after verification as being accurate and complete microfilm or magnetic media records kept at the pharmacy records kept at the lab Photographic negatives FDA's ICH E6 Good Clinical Practice: Consolidated Guidance (
4 2. Def: Copies The use of copies as described in the ICH guidance, generally applies to situations where original records are copied to a different media for archiving purposes and the originals are destroyed.
5 3. Def: Certified Medical Record A copy of Patient s medical records authenticated, as an accurate and complete representation of the original, having all of the same attributes and information, by the licensee or health care facility, as appropriate. (page 112) the FDA accepts, as equivalent to the original source document, copies or transcriptions certified after verification as being accurate and complete. This process produces what is known as a "certified copy". A certified copy is one that preserves all of the attributes of the original source document and that is dated and signed as a testament/documentation that the copy of the document is an exact copy of the Patricia M. Beers Block Good Clinical Practice Program (HF-34) Office of Science and Health Coordination Office of the Commissioner/ FDA 5600 Fishers Lane, Rm. 14B17 Rockville, MD :301/
6 How To Certifying a Medical Record The FDA & various sponsors agree that there are many ways to certify a record. The process can vary from site to site The following are the key steps:
7 How to Certify a Medical Record STEP 1: 1If it is decided to have a certified copy substitute for the original, it would be desirable to have an SOP describing how such copies would be made, verified and documented. It should explain where the medical records are located (in hard copy medical record chart or source research shadow chart).
8 Some sites use tools like these Some sites use tools like these charts to indicate how & where records will be kept. This is part of the SOP.
9 How to Certify a Medical Record STEP 2: 1. 2 The person who certifies the copy as an accurate and complete representation of the original, having all of the same attributes and information, should be the same person who actually made the copy from the original.
10 How to Certify a Medical Record STEP 3: Certification can be accomplished by initialing and dating each copy or by initialing and dating a document certifying copies in bulk. Many UCSF sites use a Certified stamp to stamp, date and initial each page of the medical record that is copied. Another option is to use a Form to certify the packet of copies.
11 This is a This is a sample form from a sponsor
12 This is a sample form from the CA Medical Board site I do not have permission to copy this form. Please see the website below to view.
13 Take home message is: Set up a process now and follow it. This will show due diligence, that the PI is providing the complete medical record for research monitoring.
14 What does the FDA say about Copies of Electronic Records? we recommend that the copying process used produces copies that preserve the content t and meaning of the record. Title 21 CFR Part 11, Electronic Records; Electronic Signatures Scope and Application
15 How will APEX change all this? The processes have not been finalized, but we are working to attain the following: 1 To provide monitors/auditors electronic accounts for temporary use, with limited access to medical data 2 All data from STOR, and Ucare will be transferred into APEX, so there will be fewer sources of data 3 All consents/assents and HIPAA documents will be scanned into APEX
16 How will APEX change all this? Some of the unanswered questions: 1Will monitors need to renew access before each visit? How long will their access be good for? Will they see all records related to a patient or just those related to the study, and if the records are limited who will set the parameters? 2.. 3If the consents/assents and HIPAA will all be store in APEX, will original signed consents still be required?
17 What are your questions? If you have specific questions that were not addressed here please me at: Danusia Filipowski, MD Perhaps your questions will be the subject of our next seminar we are always looking for new topics that are of interest to you.
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