Clinical and TranslationalClinical and TranslationalScience Institute / CTSIat the University of California, San Francisco

Update on Monitoring & Electronic Medical Records

at UCSF Danusia Filipowski, MDp ,Director, CRC-Core UCSF CTSIFilipowskid@gcrc.ucsf.edu415/476-4216January 10, 2012January 10, 2012

This discussion will include:

Certified Medical Records

Cli i l R h & M di l R d i APEX Clinical Research & Medical Records in APEX

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 & Oth i h di i d d d t fX-rays & Other images pharmacy dispensing records

recorded data from automated instruments

reports copies or transcriptions after verification as being

microfilm or magnetic media

– FDA's ICH E6 Good Clinical Practice: Consolidated Guidance ( http://www.fda.gov/cder/guidance/959fnl.pdf

gaccurate and complete

records kept at the pharmacy records kept at the lab Photographic negatives

2. Def: Copies

The use of copies as described in the ICH guidance, generally applies to situations where original records aregenerally 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 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 appropriatehealth care facility, as 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 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 thatdocument 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 sitep y

• The following are the key steps:

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 anfor the original, it would be desirable to have an SOP describing how such copies would be made, verified and documented. It should explain where h di l d l d (i h dthe medical records are located (in hard copy medical record chart or source research ‘shadow’ chart).)

Some sites use tools like theseSome sites use tools like these charts to indicate how & where records will be kept. This is part of the SOP.

How to Certify a Medical Record

STEP 2:

① .

② The person who certifies the copy as an accurate② 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 madeshould be the same person who actually made the copy from the original.

How to Certify a Medical Record

STEP 3:

① . ② .

③Certification 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.A th ti i t F t tif th k t f i Another option is to use a Form to certify the packet of copies.

This is aThis is a sample form from a sponsor

This is a sample form from the CA

I do not have permission to copy this form. Please see the website below to viewthe CA

Medical Board site

to view.

Board 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 providing the complete medical record for p g presearch monitoring.

What does the FDA say about Copies of El t i R d ?Electronic Records?

we recommend that the copying process used produces copies that preserve the

t t d i f th dcontent and meaning of the record.• 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 ① pfor temporary use, with limited access to medical data

② All d t f STOR d U ill b② 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

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 p j 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 MDDanusia Filipowski, MD filipowskid@gcrc.ucsf.edu

P h ti ill b th bj t f• Perhaps your questions will be the subject of our next seminar… we are always looking for new topics that are of interest to younew topics that are of interest to you.