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Transcript of Research Documentation: What to Write, What to Save, How to Store It Tracy Rightmer, J.D. Compliance...
Research Documentation: What to Write, What to Save, How to Store It
Tracy Rightmer, J.D.
Compliance Manager
December 16, 2008
Objectives
Discuss essential elements of a data and document management plan
Present strategies for efficient management of research related documentation
Highlight effective tools for use in managing study files
Discuss some common audit findings Describe measures for ensuring subject
confidentiality and data storage
International Conference on Harmonization
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration
ICH
The purpose is to make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines
E6:Good Clinical PracticeConsolidated Guidance
An international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials
GCP
Compliance with this standard provides public assurances that the rights, safety and well-being of trial subjects are protected, consistent with the Declaration of Helsinki, and that the clinical trial data are credible
Provide a unified standard to facilitate internal acceptance of clinical data by the regulatory authorities in these jurisdictions
GCP 2.10
All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification
Documentation is Essential
“If it isn’t documented, it didn’t happen” Viewed as a bother, but invaluable if a
problem arises No one method is mandatory (no one-
size-fits-all solution) But there are certain essential
elements
Range of Complexity
Simple anonymous survey or use of de-identified existing samples
Versus
Multi-site coordination of a double-blinded drug study with 12 visits over two years
Jargon
“Regulatory Binder” “Case Report Forms” “Source Documentation” (original
documents, data and records, such as hospital records, lab reports, subjects’ diaries, pharmacy records, etc.)
Jargon
Memo To File or Note to File An amendment is an amendment (Study personnel added via
amendment)
Approaches to research documentation
Chronological
By topic/section
Some combination of the two
Maintain copies of all final documents
History or ‘bread-crumb trail’ or ‘show your work’
Word-processing functions such as ‘track changes’
Header/footer use for version/dates Version Control: only one version is
‘active’ at a point in time Future electronic submission will
necessitate strict electronic version control
Important sections of a regulatory binder
Protocol (including all amendments and all versions)
Consent forms and HIPAA research authorization forms (approved by IRB)
Regulatory approvals (IRB, RSC, PRC, etc) and any required reapprovals
Important sections, cont’d
All correspondence, including emails, letters, faxes, notes of phone calls
Signature log, including name, initials, signature, dates of involvement, and study responsibilities
Recruitment materials, including letters, advertisements, flyers, website postings, etc (approved by IRB)
Delegation of Responsibilities Log SAMPLE FORM
Note: The PI is ultimately responsible for all aspects of the study. Title/Study #:__________________________________________________________________________________________________________ Principal Investigator: ____________________________Coordinator: _____________________ Facility/Department/Division:_____________________________________________________
*Record staff responsibilities using the following codes, list all that apply: A) Subject Recruitment D) Assesses Subject for Adverse Events G) Regulatory Reporting/Paperwork B) Obtains Informed Consent E) Administers Study Medications H) Data Management C) Performs Study Assessments F) Drug Accountability I) Other: _____________________
Training
Obligation PI Signature and Date Study Personnel
Printed Name Title Study Personnel
Role (e.g. PI, Investigator,
Coordinator,
Pharmacist, etc.)
Responsibilities* (List all letters
that apply) Date
Signature of Study Personnel
Initials of Study
Personnel Start Date
End Date
Important sections, cont’d
Samples of all forms to be used for data collection, including screening logs, eligibility checklists, case report forms, drug accountability logs
Assessment tools to be used
Any subject who signs a consent form is considered enrolled regardless of whether they are screen failures.
Use the appropriate number that applies. * ** *** Race/Ethnicity Screen Failures Reasons for Withdrawals 1. American Indian or Alaska Native 1. Subject did not meet entry criteria(s) 1. Subject's request 2. Asian 2. Subject withdrew consent 2, AE/SAE 3. Native Hawaiian or Other Pacific Islander
3. Lost to follow-up 3. Lost to follow-up
4. Black or African American 4. Other, specify in comments. 4. Protocol non-compliance 5. White 5. Death 6. More Than One Race 6. Other, specify in comments. 7. Unknown or Not Reported
Screening Enrollment Study Completion
# Screen Date ID # Gender
Race/ Ethnicity
*
Screen failure
Reason ** Consented By
Date ICF Signed
Date of Study Completion or
Early Withdraw
Reason for withdrawal
*** Comments 1
Hispanic
2 Hispanic
3 Hispanic
4 Hispanic
5 Hispanic
6 Hispanic
7 Hispanic
8 Hispanic
9 Hispanic
10 Hispanic
Important sections, cont’d
Any reporting requirements, such as Annual report to FDA Continuing review approved by IRB Adverse event reports Protocol deviation/violation reports Evidence of periodic monitoring (per the
protocol’s DSMP) DSMB recommendations (if any)
Important sections, cont’d
Versions of all sponsor materials, if applicable, including: Sponsor’s clinical protocol, Investigator’s Brochure, Amendments, Sponsor’s correspondence Records of monitoring visits
ICH Essential Documents
Those documents which individually and collectively permit evaluation of a trial and the quality of the data produced
Focus heavily on pharmaceutical- sponsored trials Include groups of documents, generated
before the trial commences, during the clinical trial, and after termination of the study
GCP Essential Documents
Many sponsor-related items, such as CVs of investigators 1572s Laboratory certifications Laboratory normal values Master randomization list with plan to
decode
Individual Subject Files
Consent form and RAF, signed and dated* Eligibility Checklist Enrollment note Visit flowchart Case report forms Lab data AE summary Patient diaries
Enrollment Note Template SAMPLE FORM
[It is recommended that investigators create enrollment notes when enrolling subjects into their study to document the consent process. This template is offered as a guide but investigators are encouraged to create their own study specific templates as appropriate or to use a written (rather than check list) form of enrollment note to fit their individual needs.] Title/Study #: Principal Investigator: Subject Name: _________________________ ID#: _________________________ Yes No 1. Subject has met inclusion criteria.
2. Subject has no exclusion criteria.
3. Informed consent was obtained prior to any study procedures being performed.
4. Subject was provided with an explanation of study procedures, risks, benefits, and alternatives, was given the opportunity to ask questions, and agrees to participate.
5. Subject was given a copy of the informed consent.
6. Contact information of research staff given to subject.
7. Additional information:
Signature ________________________________________ Date _____________
*Separate storage
Signed consent forms
Key linking identifiers to codes
Study Termination/Close-out
Final report Publication Retention and storage of regulatory
documents per requirements
More complex scenarios
Yale PI is the Sponsor-investigator of an IND, or the lead investigator on a multi-site study
Additional responsibilities, including maintaining CVs and training certificates of all personnel from all sites, and IRB approvals (and reapprovals) from all sites
Multi-site coordination
Lead PI is responsible for data integrity and data and safety monitoring
Monitoring is an evaluation of the clinical research process which should occur throughout the life of the protocol
Lead PI is responsible for informing all co-investigators of progress, and events such as SAEs, etc
Common Audit Findings
ICF Issues52%
Training21%
Eligibility16%
AEs11%
Famous Last Words
We always do our safety follow-up phone contacts.
The PI verifies all subjects’ eligibility before enrollment.
We ask about AEs at every visit.
The 1st Rule to Data Storage How do I store my data?
SECURELY!
Data Security
Recent developments: Loss of a CD with identified data Theft of a laptop with identified data Theft of a desktop computer with
identified data Theft of a briefcase with identified data
Best practices
Work in progress Several task forces working on these
issues Review some basics to think about
and incorporate into practice
Confidentiality
Common Rule has always required that confidentiality be protected to the extent possible
Good medical practice also incorporates pledges of confidentiality
Steps must be taken to minimize the risk of breaches of confidentiality
Common Rule definition
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record)
Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects
HIPAA
Adds layers of ensuring privacy and data security
HIPAA Security focuses on electronic media, but Privacy covers all forms of data
Uses somewhat different definitions
Both CR and HIPAA
Need to get permission to access, share personal information, via consent or authorization.
If authorized, sharing is allowed per the specifics of the approved documents
Jargon
Anonymous Coded De-identified
Terms are not synonymous!
Jargon
Anonymous:1: not named or identified <an
anonymous author> <they wish to remain anonymous>2 : of unknown authorship or origin <an anonymous tip>3 : lacking individuality, distinction, or recognizability
Merriam-Webster, on-line
Jargon
Coded: a system used for brevity or secrecy of
communication, in which arbitrarily chosen words, letters, or symbols are assigned definite meanings
Dictionary.com
Implies there is a link somewhere
Jargon
De-identified: Not a word Usually thought to refer to stripping the
18 HIPAA identifiers (including dates) So may be more stringent than
anonymous, but also could be coded or not
Jargon
Anonymous is not de-identified nor coded
Some use the term ‘no identifiers’
Anonymous should be reserved for situations when there are no identifiers and no code to link back
Anonymous would allow recording of dates
Coded
Some code is used to track subjects and their data
Must be master file listing identifiers (name) with code to allow decoding, addition of new data
NEVER store the link with the data
Separate means separate!
Jargon
Moveable media: CDs, diskettes, jump drives, laptops, palm tops, Blackberry, flash drives, Encryption
Secure networks Password
protection
Advice
Do not keep data with identifiers on moveable media
May become more than just advice
Advice
“Tell them never to leave their laptops in the back seat of the car.”
Kristina Borror,
OHRP
Other methods to secure data
Password protection Fingerprinting Auto log-off Lock-down cables on laptops Restrictions on downloading
Confidentiality section of the HIC application
Describe all sites where data will be used or stored
Describe how the data will be transmitted or transported
Describe specifically who will have access Describe how the data will be secured If copies of data are on moveable media,
describe security measures for these media
Sharing with co-investigators
Avoid unprotected email Coded data best
Destruction
Old data/old computers Via ITS, Procedure 1609, Media Control:
http://mire.med.yale.edu/hipaapolicies/ When use or retention of any media containing confidential information
(including protected health information) is completed, the confidential information must be destroyed, rendered unrecoverable, or returned to the system owner.
The primary means for electronic media reuse is zeroing, or degaussing and the primary means for electronic media disposal is zeroing, degaussing, or physical destruction, as applicable to the medium.
Deleting data or reformatting the disk is NOT if electronic media contains electronic Protected Health Information or other confidential information.
Destruction cont.
Zeroing uses a disk utility (e.g., Data Removal Service software) to write “zero” to all areas of a disk, thereby overwriting any data that may be on the disk. Zeroing is required rather than simply formatting or initializing the disk which simply marks the disk as blank, so that it only appears empty - other disk utilities are available that can "unformat" the disk and recover the data, so formatting/reformatting is not an acceptable practice.
Degaussing or demagnetizing is a procedure that reduces the magnetic flux on the disk to virtual zero by applying a reverse magnetizing field. Degaussing a magnetic storage medium removes all the data stored on it.
In general, other electronic media (DVD, CD, diskette, zip drive etc.,) must be physically destroyed to be rendered unreadable.
Medical campus: use the online instructions or contact the ITS-Med Help Desk http://its.med.yale.edu/help/
Conclusions
Take steps to develop a specific document management plan tailored to the protocol
Take steps to implement data security measures
Stay tuned!
References
Common Rule: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
ICH GCP: http://www.fda.gov/cder/guidance/959fnl.pdf
HIPAA Privacy and Security: http://info.med.yale.edu/hic/hipaa/index.html
Quotable Quotes
If it isn’t documented, it didn’t happen No one-size-fits-all solution How do I store my data? Securely! Bread-crumb trail Separate means separate An amendment is an amendment