Documentation of Human Documentation of Human Subjects Research in the Subjects Research in the Patient’s Health RecordPatient’s Health Record

Kimberly Summers, PharmDKimberly Summers, PharmDAssistant Chief for Clinical ResearchAssistant Chief for Clinical Research

South Texas Veterans Health Care SystemSouth Texas Veterans Health Care SystemResearch & Development ServiceResearch & Development Service

Policy Memorandum 151-07-08Policy Memorandum 151-07-08

• PurposePurpose– Provide specific directions and procedures for Provide specific directions and procedures for

the documentation of human research the documentation of human research activities conducted at STVHCS in a patient’s activities conducted at STVHCS in a patient’s health record when a patient is participating in health record when a patient is participating in a human research studya human research study

• Documentation must be part of the Documentation must be part of the patient’s legal health recordpatient’s legal health record

Patient’s Legal Health RecordPatient’s Legal Health Record

• A patient’s health record includes the A patient’s health record includes the electronic medical record (CPRS) and any electronic medical record (CPRS) and any additional hard copy documents located in additional hard copy documents located in Medical RecordsMedical Records

• Research files maintained by the PI and/or Research files maintained by the PI and/or research staff are research staff are NOTNOT part of the legal part of the legal health recordhealth record

Why is documenting research Why is documenting research procedures in the patient’s legal procedures in the patient’s legal health record important and why health record important and why

is it mandatory?is it mandatory?

Findings from the VA Office of Findings from the VA Office of Inspector GeneralInspector General

• Inconsistent and incomplete documentation of Inconsistent and incomplete documentation of research visitsresearch visits– Protocols collected clinically relevant information and Protocols collected clinically relevant information and

involved administration of medications, however no involved administration of medications, however no documentation was found regarding visits or results of documentation was found regarding visits or results of assessments or testing in the medical recordassessments 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 May compromise the ability of all providers involved in

the patient’s care to assess the current status of the the patient’s care to assess the current status of the patient’s health problempatient’s health problem

Research Record Must Be Created In Research Record Must Be Created In The Legal Medical Record WhenThe Legal Medical Record When

• Informed consent is obtainedInformed consent is obtained– Must flag medical record to indicate patient is enrolled in a research Must flag medical record to indicate patient is enrolled in a research

studystudy

• 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 Information needed by other providers to ensure the protection and

continued care of subjectscontinued care of subjects– Research requires the use of any clinical resources such as Research requires the use of any clinical resources such as

laboratory or pharmacylaboratory or pharmacy– Research visit includes physical exam findings, medical interventions Research visit includes physical exam findings, medical interventions

or testing, side effects or adverse events from an investigational or testing, side effects or adverse events from an investigational medicationmedication

• Disenrollment or termination from a studyDisenrollment or termination from a study– Must flag medical record to indicate patient is no longer participating Must flag medical record to indicate patient is no longer participating

in the research studyin the research study

Research Record Must Contain• Copy of the signed and dated consent and initial enrollment Copy of the signed and dated consent and initial enrollment

progress noteprogress note– Scanning of VA Form 10-1086 (Informed Consent Scanning of VA Form 10-1086 (Informed Consent

Document)Document)– Use of Enrollment / Consent templateUse of Enrollment / Consent template

• Information on possible drug interactions and adverse effects Information on possible drug interactions and adverse effects of investigational drugs being administeredof investigational drugs being administered– Scanning of VA Form 10-9012 (Investigational Drug Scanning of VA Form 10-9012 (Investigational Drug

Information Record)Information Record)• Any research information which has the potential to impact Any research information which has the potential to impact

medical caremedical care– Research progress notesResearch progress notes

Enrollment Consent Template: Enrollment Consent Template: Research Consent / Enrollment NoteResearch Consent / Enrollment Note

• Must be entered into the subject’s health record Must be entered into the subject’s health record (CPRS) after IC has been obtained(CPRS) after IC has been obtained

• Template in CPRS flags patients Medical Record Template in CPRS flags patients Medical Record in postingsin postings

• Template contains all the required information for Template contains all the required information for documentation of consent processdocumentation of consent process

• Template must be used in order to scan IC Template must be used in order to scan IC documentdocument

• Note must indicate if the study involves the use of Note must indicate if the study involves the use of investigational medicationsinvestigational medications

Documentation of IC ProcessDocumentation of IC Process

• Research Consent / Enrollment note may Research Consent / Enrollment note may be entered by:be entered by:– Person obtaining the signed IC orPerson obtaining the signed IC or

OROR– Study staff member documenting the IC Study staff member documenting the IC

process onlyprocess only• Recommend note is co-signed by the person who Recommend note is co-signed by the person who

obtained the signed IC and/or the PIobtained the signed IC and/or the PI

• Investigator should keep the original Investigator should keep the original signed IC in the subjects research recordsigned IC in the subjects research record– A copy is submitted to MR for scanningA copy is submitted to MR for scanning

If the study involves the use of If the study involves the use of investigational medicationsinvestigational medications

VA Form 10-9012VA Form 10-9012

Investigational Drug Information Record Investigational Drug Information Record (VA Form 10-9012)(VA Form 10-9012)

• Required forRequired for– Investigational drug for which an IND has been filedInvestigational drug for which an IND has been filed– Approved drug being studied for unapproved use in a Approved drug being studied for unapproved use in a

controlled, randomized, or blinded clinical trialcontrolled, randomized, or blinded clinical trial– Approved drug being studied for approved use in a Approved drug being studied for approved use in a

controlled, randomized, or blinded clinical trialcontrolled, randomized, or blinded clinical trial

• PI must ensure a completed and signed copy is PI must ensure a completed and signed copy is submitted to MR for scanningsubmitted to MR for scanning

• Pharmacy will not dispense any study Pharmacy will not dispense any study medication for a research subject until all 10-medication for a research subject until all 10-9012 forms have been scanned 9012 forms have been scanned

Updated Consent Template: Updated Consent Template: Research Consent / Update NoteResearch Consent / Update Note

• Any changes to the IC resulting in an Any changes to the IC resulting in an addendum or updated IC document addendum or updated IC document – Must be entered into the subject’s health Must be entered into the subject’s health

record (CPRS) after IC has been obtainedrecord (CPRS) after IC has been obtained– Template in CPRS flags patients Medical Template in CPRS flags patients Medical

Record in postingsRecord in postings

• All IC addendums and updated IC All IC addendums and updated IC documents must be scanned in CPRSdocuments must be scanned in CPRS

Scanning and Electronic AttachmentScanning and Electronic Attachment

• Assigned as a priority for Medical Records staffAssigned as a priority for Medical Records staff– 24 hour turn around in place24 hour turn around in place– Submit good quality, dark copies for scanningSubmit good quality, dark copies for scanning– Assure no pages are missing from the ICAssure no pages are missing from the IC– Assure there are patient identifiers on all pagesAssure 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 The enrollment / consent or consent / update progress note must be completed and progress note must be completed and signedsigned prior to scanning prior to scanning – IC and Drug Information Record will be linked to the IC and Drug Information Record will be linked to the

same CPRS progress notesame CPRS progress note

Stat ScanningStat Scanning

• If scanning is required immediately for the If scanning is required immediately for the dispensing of medication on the same day as dispensing of medication on the same day as signing informed consentsigning informed consent

• Contact:Contact:– Anthony Salvangno x 16067Anthony Salvangno x 16067– Rey Flores x 15605Rey 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 Please do not abuse this system it is only for

situations were dispensing of medications in less situations were dispensing of medications in less than 24 hours of initial consenting is neededthan 24 hours of initial consenting is needed

Research Progress NotesResearch Progress Notes

• All progress note titles will be standardized All progress note titles will be standardized – Titles will start with Research ……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 Provide the R&D office with the names of all current

templates used for research in your departmenttemplates used for research in your department– Templates not used within 1 year are deletedTemplates 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 Assure your documentation in the progress note

fits with your approved scope of practicefits with your approved scope of practice

Research Disenrollment Research Disenrollment Termination NoteTermination Note

• Must be entered into the subject’s health Must be entered into the subject’s health record (CPRS) record (CPRS)

• Template in CPRS flags patients Medical Template in CPRS flags patients Medical Record in postingsRecord in postings

• Required information in templateRequired information in template– Title of StudyTitle of Study– Date of disenrollment or terminationDate of disenrollment or termination– Contact name and number Contact name and number

Flagging in Medical Record Under Flagging in Medical Record Under Postings in CPRSPostings in CPRS

• CWADCWAD– Crisis notes, Warning notes, DirectivesCrisis notes, Warning notes, Directives

• Entered for allEntered for all– Consent enrollment notesConsent enrollment notes– Consent update notesConsent update notes– Consent disenrollment notesConsent disenrollment notes

*CPRS Templates must be used to flag record*CPRS Templates must be used to flag record

VA Compliance Office VA Compliance Office

• Conduct focused reviews of research Conduct focused reviews of research documentationdocumentation

• Will verify consent enrollment , consent update, Will verify consent enrollment , consent update, and disenrollment notes are entered in CPRSand disenrollment notes are entered in CPRS– Signed VA informed consents are scannedSigned VA informed consents are scanned– Investigational drug forms (Form 10-9012) are Investigational drug forms (Form 10-9012) are

scannedscanned

• Will verify research visits are documented in Will verify research visits are documented in accordance with the requirements of VHA accordance with the requirements of VHA Handbook 1200.1 and STVHCS PoliciesHandbook 1200.1 and STVHCS Policies

Questions?Questions?

Kimberly Summers, PharmDKimberly Summers, PharmD

Office: (210) 617-5300 ext 15969Office: (210) 617-5300 ext 15969

Email: kimberlyk.Summers@va.govEmail: kimberlyk.Summers@va.gov