1. Documentation of Human Subjects Research in the Patient’s Health Record Kimberly Summers, PharmD Assistant Chief for Clinical Research South Texas Veterans Health Care System Research & Development Service

2. Policy Memorandum 151-07-08 PurposePurpose –Provide specific directions and procedures for the documentation of human research activities conducted at STVHCS in a patient’s health record when a patient is participating in a human research study Documentation must be part of the patient’s legal health recordDocumentation must be part of the patient’s legal health record

3. Patient’s Legal Health Record A patient’s health record includes the electronic medical record (CPRS) and any additional hard copy documents located in Medical RecordsA patient’s health record includes the electronic medical record (CPRS) and any additional hard copy documents located in Medical Records Research files maintained by the PI and/or research staff are NOT part of the legal health recordResearch files maintained by the PI and/or research staff are NOT part of the legal health record

4. Why is documenting research procedures in the patient’s legal health record important and why is it mandatory?

5. Findings from the VA Office of Inspector General Inconsistent and incomplete documentation of research visitsInconsistent and incomplete documentation of research visits –Protocols collected clinically relevant information and involved administration of medications, however no documentation was found regarding visits or results of assessments or testing in the medical record Violation of VHA Handbook 1907.1Violation of VHA Handbook 1907.1 –May compromise the ability of all providers involved in the patient’s care to assess the current status of the patient’s health problem

6. Research Record Must Be Created In The Legal Medical Record When Informed consent is obtainedInformed consent is obtained –Must flag medical record to indicate patient is enrolled in a research study A research visit has the potential to impact medical careA research visit has the potential to impact medical care –Information needed by other providers to ensure the protection and continued care of subjects –Research requires the use of any clinical resources such as laboratory or pharmacy –Research visit includes physical exam findings, medical interventions or testing, side effects or adverse events from an investigational medication Disenrollment or termination from a studyDisenrollment or termination from a study –Must flag medical record to indicate patient is no longer participating in the research study

7. Research Record Must Contain Copy of the signed and dated consent and initial enrollment progress noteCopy of the signed and dated consent and initial enrollment progress note –Scanning of VA Form 10-1086 (Informed Consent Document) –Use of Enrollment / Consent template Information on possible drug interactions and adverse effects of investigational drugs being administeredInformation on possible drug interactions and adverse effects of investigational drugs being administered –Scanning of VA Form 10-9012 (Investigational Drug Information Record) Any research information which has the potential to impact medical careAny research information which has the potential to impact medical care –Research progress notes

8. Enrollment Consent Template: Research Consent / Enrollment Note Must be entered into the subject’s health record (CPRS) after IC has been obtainedMust be entered into the subject’s health record (CPRS) after IC has been obtained Template in CPRS flags patients Medical Record in postingsTemplate in CPRS flags patients Medical Record in postings Template contains all the required information for documentation of consent processTemplate contains all the required information for documentation of consent process Template must be used in order to scan IC documentTemplate must be used in order to scan IC document Note must indicate if the study involves the use of investigational medicationsNote must indicate if the study involves the use of investigational medications

12. Documentation of IC Process Research Consent / Enrollment note may be entered by:Research Consent / Enrollment note may be entered by: – Person obtaining the signed IC or OR –Study staff member documenting the IC process only Recommend note is co-signed by the person who obtained the signed IC and/or the PIRecommend note is co-signed by the person who obtained the signed IC and/or the PI Investigator should keep the original signed IC in the subjects research recordInvestigator should keep the original signed IC in the subjects research record –A copy is submitted to MR for scanning

13. If the study involves the use of investigational medications

14. VA Form 10-9012

15. Investigational Drug Information Record (VA Form 10-9012) Required forRequired for –Investigational drug for which an IND has been filed –Approved drug being studied for unapproved use in a controlled, randomized, or blinded clinical trial –Approved drug being studied for approved use in a controlled, randomized, or blinded clinical trial PI must ensure a completed and signed copy is submitted to MR for scanningPI must ensure a completed and signed copy is submitted to MR for scanning Pharmacy will not dispense any study medication for a research subject until all 10- 9012 forms have been scannedPharmacy will not dispense any study medication for a research subject until all 10- 9012 forms have been scanned

16. Updated Consent Template: Research Consent / Update Note Any changes to the IC resulting in an addendum or updated IC documentAny changes to the IC resulting in an addendum or updated IC document –Must be entered into the subject’s health record (CPRS) after IC has been obtained –Template in CPRS flags patients Medical Record in postings All IC addendums and updated IC documents must be scanned in CPRSAll IC addendums and updated IC documents must be scanned in CPRS

20. Scanning and Electronic Attachment Assigned as a priority for Medical Records staffAssigned as a priority for Medical Records staff –24 hour turn around in place –Submit good quality, dark copies for scanning –Assure no pages are missing from the IC –Assure there are patient identifiers on all pages Will need to write in identifier on Drug Information RecordWill need to write in identifier on Drug Information Record The enrollment / consent or consent / update progress note must be completed and signed prior to scanningThe enrollment / consent or consent / update progress note must be completed and signed prior to scanning –IC and Drug Information Record will be linked to the same CPRS progress note

21. Stat Scanning If scanning is required immediately for the dispensing of medication on the same day as signing informed consentIf scanning is required immediately for the dispensing of medication on the same day as signing informed consent Contact:Contact: –Anthony Salvangno x 16067 –Rey Flores x 15605 Scanning will be completed within 15 minScanning will be completed within 15 min Please do not abuse this system it is only for situations were dispensing of medications in less than 24 hours of initial consenting is neededPlease do not abuse this system it is only for situations were dispensing of medications in less than 24 hours of initial consenting is needed

22. Research Progress Notes All progress note titles will be standardizedAll progress note titles will be standardized –Titles will start with Research …… Current note templates can be renamedCurrent note templates can be renamed –Provide the R&D office with the names of all current templates used for research in your department –Templates not used within 1 year are deleted Progress note template available in CPRSProgress note template available in CPRS Assure your documentation in the progress note fits with your approved scope of practiceAssure your documentation in the progress note fits with your approved scope of practice

26. Research Disenrollment Termination Note Must be entered into the subject’s health record (CPRS)Must be entered into the subject’s health record (CPRS) Template in CPRS flags patients Medical Record in postingsTemplate in CPRS flags patients Medical Record in postings Required information in template Required information in template –Title of Study –Date of disenrollment or termination –Contact name and number

29. Flagging in Medical Record Under Postings in CPRS CWADCWAD –Crisis notes, Warning notes, Directives Entered for allEntered for all –Consent enrollment notes –Consent update notes –Consent disenrollment notes *CPRS Templates must be used to flag record

31. VA Compliance Office Conduct focused reviews of research documentationConduct focused reviews of research documentation Will verify consent enrollment, consent update, and disenrollment notes are entered in CPRSWill verify consent enrollment, consent update, and disenrollment notes are entered in CPRS –Signed VA informed consents are scanned –Investigational drug forms (Form 10-9012) are scanned Will verify research visits are documented in accordance with the requirements of VHA Handbook 1200.1 and STVHCS PoliciesWill verify research visits are documented in accordance with the requirements of VHA Handbook 1200.1 and STVHCS Policies

32. Questions? Kimberly Summers, PharmD Office: (210) 617-5300 ext 15969 Email: kimberlyk.Summers@va.gov