Stanley Estime, MSCI
October 19, 2015
Record Keeping: What is Regulatory Documentation and how should it be maintained?
Tel: 617-432-2164E-mail: [email protected]
URL: www.hsph.harvard.edu/ohra/qip
2
Today’s Agenda
QIP Regulatory Binder– Review of Contents/Sections
Tips for Successful Record Keeping QIPs Electronic Record Keeping Applications: eRegulatory
Binder (REDCap) & eBox (Box.Com)
3
QIP Regulatory Binder
Based on GCP list of Essential Documents and OHRA’s Recordkeeping/Record Retention requirements
Provides a template for maintaining and organizing documentation to ensure compliance with federal regulations, institutional policies and good clinical practice
– Alternatives exist: You can create your own way of organizing these documents that works best for you and your study team just BE CONSISTENT
QIP provides record keeping recommendations and a regulatory binder based on best practices
A study specific Binder will be provided based on the type of research being conducted (e.g., Social Behavioral, Biomedical, or FDA)
4
Binder Sections Overview(Essential Documents)
Study-Specific: Lab Documents FDA Investigational Brochure Drug/Device Financial Disclosure NIH Sponsor DSMB Local Review
All Studies: Protocol Staff CVs Staff Licensures Logs IRB Documents Consent Forms Data Collection Training
5
Essential Documents (All Studies) Section Purpose Considerations/
Recommendations
Protocol Demonstrates investigator and/or sponsor agreement to the protocol. Highlights current study objectives and procedures.
Ensure that the version number/date reflects the current protocol.
CVs and licensures
Confirms staff qualifications to conduct a study or perform delegated tasks.
CVs and licenses should be updated every 2 years to confirm that the information is accurate and current.
Staff should sign and date CVs
Maintain licensures for staff conducting clinically study related procedures
6
Essential Documents (All Studies)
Section Purpose Considerations/
Recommendations
Logs Assists with the collection of data that is required by or reported to the IRB or other regulatory authorities (e.g., Staff Delegation of Responsibility Log)
Information in logs can be customized to fit a specific study or added to existing electronic versions currently maintained on site.
IRB Documents
Demonstrates that the IRB have reviewed and approved the study prior to initiation and continuing review, protocol modifications and reportable new information is communicated to the IRB
File correspondences for a given submission in reverse chronological order to ensure an accurate timeline from study start-up to completion.
Keep submissions, requires modifications, investigator’s response and approvals together.
7
Essential Documents (All Studies)
Section Purpose Considerations
Informed Consent Documents that information is given to participants that support their ability to give informed consent.
Maintains original copies of all IRB approved consent forms.
Ensure that staff obtaining consent is using the most recently approved consent form.
Maintain IRB approved versions on file
Data Collection Maintains original copies of all forms used to collect study data (e.g., case report forms or questionnaires/ surveys).
Only blank copies of forms should be kept in regulatory file. Participant files should be maintained separately in participant binder.
8
Essential Documents (All Studies)
Section Purpose Considerations
Training Documents adequate training for all IRB approved personnel (e.g., CITI, protocol specific or sponsor training).
Maintains documentation of all training records and certifications.
Any HSPH affiliate working directly with human subjects’ data or tissue or has access to identifiable information must fulfill CITI training requirements every 3 years.
Sponsor training requirements and timeframes may vary.
9
Study-Specific Documents
Tissue/blood Specimens Laboratory Documents
(e.g. - Director’s CV, Lab Normals and Certifications)
Drug/Device FDA 1572 (drug) or
Investigator Agreement (device)
Investigational Brochure (drug) or Device Manual (device)
IND/IDE Application
Sponsored Financial Disclosures/Agreements NIH grant application & progress
report
Data Monitoring DSMB Charter and Reports
External Review Local Ethical Approval Notice
(external IRB, ERB or CAB)
OHRA Record Retention Policy
Maintain documentation at least 7 years from study closure date
Check with sponsor to ensure compliance with their record retention policies
10
Tips for Successful Record Keeping
Address and resolve documentation problems immediately
Review documentation routinely Document and update materials in real time
11
12
Tips, continued…Electronic Recordkeeping
Maintain signed and dated note-to-file indicating the location of electronic correspondences.
Ensure that electronic copies are available to study staff and regulatory authorities.
Maintain copies of documents and correspondences with the original signatures (pdf).
REDCAP - eBinder Box.Com – eBox Binder
Server based Cloud based
Access to Data Dictionary User-friendly Interface
Customizable Assign task & reminders
Single sign-on (Novell) iOS, WebOS, Android
Highlights of Each Electronic Binder Platform
13
Demonstration of Key functions of eBinder(s)
Storing
Sharing
Searching
14
Communicating
Storing - User Interface
Uploading Documents
Sharing Data
REDCap
Box
Sharing Data Box
Searching Data
Field level searches
Searching Data
Box – File/Document level searches
Internal Communication
REDCap
Box
Communication - Notifications
E-mail notification for completed tasks
Pending and overdue task notifications
Questions?
Leslie Howes, OHRA Director ([email protected])
QA/QI Specialists
Stanley Estime ([email protected]) Lisa Gabel ([email protected]) Alyssa Speier ([email protected])
OHRA: www.hsph.harvard.edu/ohra
23