Update on Monitoring & Electronic Medical Records at UCSF: Preparing for a Clinical Research Monitoring Visit
Clinical and Translational Science Institute / CTSI at the University of California, San Francisco Update on Monitoring &Electronic Medical Records at UCSF Danusia Filipowski, MD p , Director, CRC-Core UCSF CTSI Filipowskid@gcrc.ucsf.edu January 10, 2012 415/476-4216
This discussion will include: Certified Medical Records Cli i l R Clinical Research & M di l R h Medical Records i APEX d in
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 memorandaClinical and office charts evaluation checklists laboratory notesX-rays & Oth imagesX Other i pharmacy di h dispensing i recorded d t f d d data from records automated instrumentsreports copies or transcriptions microfilm or magnetic media after verification as being g accurate and completerecords kept at the pharmacy records kept at the lab Photographic negatives – FDAs ICH E6 Good Clinical Practice: Consolidated Guidance ( http://www.fda.gov/cder/guidance/959fnl.pdf
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.
3. Def: Certified Medical Record A copy of Patient s medical records authenticated as an Patient’s authenticated, accurate and complete representation of the original, having all of the same attributes and information, by the licensee or health care facility as appropriate facility, appropriate. www.mbc.ca.gov/board/meetings/materials_2009_07-23_quarterly-7b-assembly.pdf (page 112) “the FDA accepts as equivalent to the original source document copies or the accepts, document, 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 20857 :301/827-6473
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 p y• The following are the key steps:
How to Certify a Medical RecordSTEP 1:①If it is decided to have a certified copy substitute for the original, it would be desirable to have an original SOP describing how such copies would be made, verified and documented. It should explain where the medical records are l h di l d located (i h d copy d (in hard medical record chart or source research ‘shadow’ chart). )
Some sites use tools like thesecharts to indicate how & whererecords will be kept. This is partof the SOP.
How to Certify a Medical RecordSTEP 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.
How to Certify a Medical RecordSTEP 3:① .② .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 ti i to A th option is t use a F Form to certify the packet of copies. t tif th k t f i
This is asample I do not have permission to copy thisform from form. Please see the website belowthe CA to view view.MedicalBoard site •http://www.mbc.ca.gov/forms/enf-22.pdf
Take home message is:• Set up a process now and follow it.• This will show due diligence, that the PI is p providing the complete medical record for g p research monitoring.
What does the FDA say about Copies of Electronic Records? El t i R d ? we recommend that the copying process used produces copies that preserve the content and meaning of the record. t t d i f th d• Title 21 CFR Part 11, Electronic Records; Electronic Signatures — Scope and Application
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 p for temporary use, with limited access to medical data ② All d t f data from STOR and Ucare will b STOR, d U ill be transferred into APEX, so there will be fewer sources of data ③ All consents/assents and HIPAA documents will be scanned into APEX
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 j p just those related to the study, and if the records are y, 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?
What are your questions?• If you have specific questions that were not addressed here please email me at: Danusia Filipowski, MD Filipowski firstname.lastname@example.org•P h Perhaps your questions will b th subject of ti ill be the bj t f our next seminar… we are always looking for new topics that are of interest to you you.