Verifying Source Documents

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Source Documentation

First place the data are capturedOriginal documents, data, and recordsCertified CopiesShould contain certain specific information about the participant and trial

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Working Definition of Source Documents

This information consists of all written and printed documents that are pertinent to a research participant’s:

exposure to the investigational agent(s)

exposure to other treatments progress of the disease course response to therapy

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Source Document Examples

Physician Progress NotesNurse’s NotesDiagnostic Test ReportsMedication RecordsLaboratory ResultsParticipant Diaries

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CORRECTIONS

Four items must be visible each time a raw data value is changed:

(1) The old value

(2) The new value (3) The date of the change (4) By whom the change was made. [ the reason for the change must either be apparent or an explanation provided]

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Addenda/Insertions

When text needs to be inserted, it cannot be squeezed between

lines or in margins.

Insertions should be documented as a signed addendum and placed after the last entry.

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Protecting Subject Identity

Source Documentsfull name

Documents for Sponsor/Data Mgmt.

Participant initialsrandomization numberdate of birth (optional)

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Case Report Form

Tool to collect the data and provide condensed picture of participant’s involvement in the studyNot intended to replace Source DocumentsInvestigator’s responsibility

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Ensure Good Documentation

by Knowing Your Study

ProtocolInvestigator BrochureCase Report Form guidelinesLab proceduresMedication RequirementsSponsor requirementsRegulations

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What the Monitor will verify

GCP and Federal Requirements (ICH, OHRP, FDA)Sponsor requirementsProtocol Adherence

“We monitor by the protocol”

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Verifying Source Documents

Ensure that source data is complete, accounted for, follows a logical sequence of events, and that source data supports entries in CRF

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Performing Logic Checks

Recreate the scenario: who did what, when, where, how, and whyDetermine the impact an event has elsewhere (med. hx., con. meds., AEs)Note inconsistencies

Dr. notes no complaintsNurse documents multiple complaints from same subject on same day

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Protocol Required Documentation

All inclusion/exclusion criteria addressed

Study required tests and procedures done on time or if not, why not

Withdrawals, dropouts, lost to follow up

AEs/SAEs properly documented/reported

Endpoints of the study

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Access to Source Documentation

Investigator’s responsibilitiesIRB/IECSponsor

contractor of the sponsor such as PPD

Regulatory agency (FDA, OHRP)

Investigator agreement and informed consent authorize access to records

DAIT Source Document SOP

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DAIT Source Documentation SOP

Data must be verifiableNeeds an audit trailALCOA*

Attributable, Legible, Contemporaneous, Original, Accurate

*Source: “The Facts About Source Documents”

» Stan Wollen, Presented at 1999 DIA Mtg..

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DAIT SD SOP

FormatSD specific item noted

RequirementSuggestionsReference

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DAIT SD SOP

AddendaAssentCRFs as SDChart NoteCommunications

writtenverbal

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DAIT SD SOP

Compliance: study drug/agentComputer RecordsConcomitant Medication: non-studyConfidentialityConsult Notes

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DAIT SD SOP

Contraception: protocol requiredCopies: certifiedDeathDeviations/ViolationsDocumentation StandardsEndpointsEntry Criteria (Inclusion/Exclusion)

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DAIT SD SOP

Error CorrectionsFlow SheetsIdentifiersInformed ConsentInitials

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DAIT SD SOP

Lab Tests: Specimen CollectionLab Tests: ResultsMedical HistoryMedical RecordsPrescriberPrescriptions

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DAIT SD SOP

Procedures: Diagnostic, Therapeutic, Surgical, etc.QuestionnairesResearch RecordSource DocumentStorage of Source Documents

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DAIT SD SOP

Study Drug/AgentStudy Drug/Agent AccountabilityToxicities: grading (adverse events, signs and symptoms, lab results)Transferring SubjectsVital Signs and other Assessments

DAIT Source Document

Site Training Questions

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Computer/Electronic Records

Is the site required to have hard copies of all patient related data in order to ensure proper monitoring? What questions will the monitor ask if they are observing subject data via a computer?

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CRFs as SD

A CRF that is being used as the SD has multiple data entries and one signature at the end of the form. Would this ever be acceptable and if so, provide specifics.

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CRFs as SD

Is it acceptable for the site to use the SAE report form as their SD of a serious adverse event? Explain the specifics.

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Certified Copies

The site has received a discharge summary via fax from a health care facility where a study subject was treated over the weekend for angina. The fax is difficult to read and looks as if some information has been covered with correction fluid (white-out).Should the coordinator certify this copy? What does the certification mean?

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Error Corrections

When would it be necessary to explain why data were changed or corrected? Provide an example.

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Informed Consent

A new version of the consent form for your study was available but enrollment at your site was completed and participants were in the follow up phase.

Should you obtain the new consent form, obtain IRB/IEC approval and ask participants to sign it?

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Informed Consent

Subject who is illiterate makes his mark on the consent form in the space for subject signature. List at least three things that need to be verified with regard to this special situation.

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Informed Consent

Who is required to sign the consent form? Provide a variety of possible answers to this question based on multiple scenarios.

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INFORMED CONSENT

The subject refuses to take a copy of the consent form and says that she does not want her husband to know that she is participating in this trial.What should be documented about this?

PATIENT PATIENT

INFORMED

INFORMED

CONSENT CONSENT

FORMFORM

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Medical Records

List the reasons why a monitor would ask the site to attempt to obtain subject medical records if they were not present in the research record.

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Reportable Events

The monitor discovered that a grade 4 event has not been reported. The coordinator stated that this event was not related to drug (though no documentation exists re: R/T drug). The investigator suggested that perhaps this event was “misgraded”.

How should the monitor and site personnel resolve this?

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Toxicities

What possible actions should site personnel take upon the discovery of laboratory toxicity? Provide multiple scenarios.

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Inconsistent SD

The study nurse writes something in the SD that conflicts with what an investigator has written. What should be the response of the site personnel who discovers this discrepancy?

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Who needs to be included?

Investigator of Record AgreementCVs

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IRB/IEC ISSUES

The DAIT/DAIDS 000 protocol approval is from 02 Oct02 - 01 Oct03. The study coordinator received a notice from the IRB that an extension has been granted due to a delay in the meeting date. What should the coordinator do?

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IRB ISSUES

What documentation should be on file if the PI is a current, voting member of the IRB?

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ERROR CORRECTIONS

An informed consent was signed 07 Jun 03 after which all relevant study investigations were carried out. The research record indicated that the consent was signed on 08 Jun 03.How will you rectify this?