CHECKLIST: Good Clinical Practice
NUMBER / DATE / PAGE
HRP-432 / 10/4/2013 / 1 of 4
For each protocol requiring ICH-GCP requirement, the PI is to complete this form with the initial submission (HRP-211). The purpose of this checklist is to allow investigators to conduct a quality improvement self-assessment, and for QA/QI staff to conduct a quality improvement assessment of investigators.
Clinical Trials
(Human Subject Research)
Principal Investigator
Protocol Name
Name of Person Completing Checklist
Date Completed
InvestigatorQualifications and Agreements / Remarks
Yes No NAGCP 4.1.1 / As theinvestigator, you arequalified byeducation,training, and experience to assume responsibilityfor the properconduct of the trial. Youmeetallthe qualificationsspecified bythe applicableregulatoryrequirement(s),and can provide evidence ofsuch qualifications through up-to-date curriculumvitae and/orotherrelevantdocumentationrequested bythesponsor, the IRB/IEC, and/ortheregulatoryauthority(ies).
Yes No NAGCP 4.1.2 / As theinvestigator, you arethoroughlyfamiliarwith the appropriate useoftheinvestigationalproduct(s),as describedin the protocol, inthe currentInvestigator's Brochure,in the productinformation,andinother information sourcesprovided bythe sponsor.
Yes No NAGCP 4.1.3 / As the investigator, you are aware of and will comply with, Good Clinical Practice guidance and applicable regulatory requirements.
Yes No NAGCP 4.1.4 / As the investigator, you permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).
Yes No NAGCP 4.1.5 / As the investigator, you maintain a list of appropriately qualified persons to whom you have delegated significant trial- related duties.
Adequate Resources / Remarks
Yes No NAGCP 4.2.1 / As the investigator, you can demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period.
Yes No NAGCP 4.2.2 / As the investigator, you have sufficient time to properly conduct and complete the trial within the agreed trial period.
Yes No NAGCP 4.2.3 / As the investigator, you have adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely.
Yes No NAGCP 4.2.4 / As the investigator, you can ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions.
Medical CareofTrial Subjects / Remarks
Yes No NAGCP 4.3.1 / As the investigator, you can ensure a qualified physician (or dentist, when appropriate), either yourself or a sub-investigator for the trial, will be responsible for all trial-related medical (or dental) decisions.
Yes No NAGCP 4.3.2 / As the investigator, you can ensure that adequate medical care is provided to a subject for any adverse events (including clinically significant laboratory values) related to the trial, both during and following a subject's participation in a trial. You will inform a subject when medical care is needed for inter- current illness(es) of which you become aware.
Yes No NAGCP 4.3.3 / As the investigator, you will inform the subject's primary physician about the subject's participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed.
Yes No NAGCP 4.3.4 / Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a trial, you will you make a reasonable effort to ascertain the reason(s), while fully respecting the subject's rights.
Communication with IRB / Remarks
Yes No NAGCP 4.4.1 / As the investigator, you have written and dated approval from the IRB for the research application, written informed consent form, consent form updates, subject recruitment procedures (e.g., advertisements), and any other written information to be provided to subjects.
Yes No NAGCP 4.4.2 / As the investigator, you will provide the IRB with a current copy of the Investigator's Brochure. If the Investigator's Brochure is updated during the trial, you will provide a copy of the updated Investigator's Brochure to the IRB.
Yes No NAGCP 4.4.3 / As the investigator, you will provide the IRB with all documents subject to review according to the IRB’s requirements.
Compliancewith theProtocol / Remarks
Yes No NAGCP 4.5.1 / As the investigator, you will conduct the research in compliance with the research application that was given approval by the IRB. You will sign the research application to confirm agreement.
Yes No NAGCP 4.5.2 / As the investigator, you will not implement any deviation from the IRB-approved research application without prior review and documented approval from the IRB of a modification. If necessary to eliminate an immediate hazard to research subjects, you may deviate from the IRB-approved research application without prospective IRB approval.
Yes No NAGCP 4.5.3 / As the investigator, you or someone designated by you, will document and explain any deviation from the approved protocol that occurs without prospective IRB approval.
Yes No NAGCP 4.5.4 / As the investigator, if you deviate from the IRB-approved research application to eliminate an immediate hazard(s) to subjects without prior IRB approval, you will submit the deviation, reason(s) for it, and if appropriate a protocol modification to the sponsor and the IRB.
Investigational Product(s) / Remarks
Yes No NAGCP 4.6.1 / As the investigator, you and/or the institution take responsibility for investigational product(s) accountability at the research site(s).
Yes No NAGCP 4.6.2 / As the investigator, you may assign some or all of your duties for investigational product(s) accountability at the research site(s) to an appropriate pharmacist or other appropriate individual who is under your supervision or the supervision of the institution.
Yes No NAGCP 4.6.3 / As the investigator, you, or an appropriate designee will, maintain records of the product's delivery to the research site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product(s). These records will include dates, quantities, batch/serial numbers, expiration dates (if applicable), and the unique code numbers assigned to the investigational product(s) and research subjects. You will maintain records that document adequately that subjects were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor.
Yes No NAGCP 4.6.4 / As the investigator, you will ensure that the investigational product(s) will be stored as specified by the sponsor and in accordance with applicable regulatory requirement(s).
Yes No NAGCP 4.6.5 / As the investigator, you will ensure that the investigational product(s) are used only in accordance with the IRB-approved research application.
Yes No NAGCP 4.6.6 / As the investigator, you or an appropriate designee will explain the correct use of the investigational product(s) to each subject. You or an appropriate designee will periodically check that each subject is following the instructions properly.
RandomizationProcedures / Remarks
Yes No NAGCP 4.7.1 / As the investigator, you will follow the trial's randomization procedures, if any. You will ensure that the code is broken only in accordance with the IRB-approved research application. If the research is blinded, you will promptly document and explain to the sponsor any premature unblinding (e.g., accidental unblinding, unblinding due to a serious adverse event) of the investigational product(s).
Informed ConsentofSubjects / Remarks
Yes No NAGCP 4.8.1 / As the investigator, you will comply with the applicable regulatory requirement(s) and adhere to GCP and to the ethical principles that have their origin in the Declaration of Helsinki in obtaining and documenting informed consent. Prior to the beginning of the research study, you will have the IRB's written approval of the written informed consent form and any other written information to be provided to subjects.
Yes No NAGCP 4.8.2 / As the investigator, you will ensure that the written informed consent form and any other written information to be provided to subjects will be revised whenever important new information becomes available that may be relevant to the subject's consent. Any revised consent form and other written information provided to subjects will receive the IRB’s approval in advance of use. The subject or the subject's legally acceptable representative will be informed in a timely manner if new information becomes available that may be relevant to the subject's willingness to continue participation in the research, and the communication of this information will be documented.
Yes No NAGCP 4.8.3 / As the investigator, neither you nor the research staff will coerce or unduly influence a subject to participate or to continue to participate in the research.
Yes No NAGCP 4.8.4 / As the investigator, you will ensure that none of the oral and written information concerning the trial, including the written informed consent form, contains any language that causes the subject or the subject's legally acceptable representative to waive or to appear to waive any legal rights, or that releases or appears to release the investigator, the institution, the sponsor, or their agents from liability for negligence.
Yes No NAGCP 4.8.5 / As the investigator, you, or an appropriate designee, will fully inform the subject or, if the subject is unable to provide informed consent, the subject's legally acceptable representative, of all pertinent aspects of the research including the written information and the approval by the IRB.
Yes No NAGCP 4.8.6 / As the investigator, you will ensure that the language used in the oral and written information about the research, including the consent form, will be as non-technical as practical and will be understandable to the subject or the subject's legally acceptable representative and the impartial witness, where applicable.
Yes No NAGCP 4.8.7 / As the investigator, you or an appropriate designee will provide the subject or the subject's legally acceptable representative ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the research. All questions about the research will be answered to the satisfaction of the subject or the subject's legally acceptable representative.
Yes No NAGCP 4.8.8 / As the investigator, you will ensure that the written consent form is signed and personally dated by the subject or by the subject's legally acceptable representative, and by the person who conducted the informed consent discussion prior to a subject's participation in any research procedures.
Yes No NAGCP 4.8.9 / As the investigator, you will ensure that, if a subject or a legally acceptable representative is unable to read, an impartial witness will be present during the entire informed consent discussion. After the written informed consent form, and any other written information to be provided to subjects, is read and explained to the subject or the subject's legally acceptable representative, and after the subject or the subject's legally acceptable representative has orally consented to the subject's participation in the trial and, if capable of doing so, has signed and personally dated the informed consent form, the witness will sign and personally date the consent form. By signing the consent form, the witness attests that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject's legally acceptable representative, and that informed consent was freely given by the subject or the subject's legally acceptable representative.
Yes No NAGCP 4.8.10 / As theinvestigator, willyou ensurethat, the informed consent discussion and the writteninformed consentformand anyotherwritteninformation provided to subjects willinclude explanations ofthefollowing:
  • Thatthetrail involvesresearch.
  • Thepurposeofthetrial.
  • The trialtreatment(s)and probabilityforrandom assignment toeachtreatment.
  • The trailprocedures to be followed, includingall invasive procedures.
  • Thesubject’s responsibilities.
  • Those aspectsofthetrial thatare experimental.
  • Thereasonablyforeseeablerisks or inconveniences tothe subjectand, when applicable, toan embryo, fetus, or nursinginfant.
  • Thereasonablyexpected benefits.When thereisno intendedclinicalbenefittothe subject,the subjectwillbe made aware ofthis.
  • Thealternative procedure(s)orcourse(s)oftreatment thatmaybe available tothesubject,andtheirimportant potentialbenefitsand risks.
  • Thecompensationand/ortreatmentavailableto the subjectintheeventof trial-related injury.
  • Theanticipatedprorated payment, ifany, to the subject forparticipatingin the trial.

  • Theanticipatedexpenses, ifany, to the subjectfor participatingin the trial.
  • Thatthe subject's participation in the trialis voluntary and thatthesubjectmayrefuse to participate orwithdraw fromthe trial,atanytime, withoutpenaltyorlossof benefits to which the subject isotherwiseentitled.
  • Thatthe monitor(s),theauditor(s),the IRB/IEC, and the regulatoryauthority(ies)willbe granted directaccess to the subject's originalmedicalrecordsforverification of clinicaltrialprocedures and/ordata, withoutviolatingthe confidentialityofthesubject,to the extentpermitted by the applicablelawsandregulations andthat, bysigninga writteninformed consentform, the subjectorthe subject's legallyacceptablerepresentativeis authorizing such access.
  • Thatrecordsidentifyingthesubjectwillbekept confidentialand,to the extentpermittedbythe applicable laws and/orregulations, willnotbe made publicly available. If theresults ofthe trialare published, the subject’sidentitywillremain confidential.
  • Thatthe subjectorthesubject's legallyacceptable representative willbeinformed in a timelymanner if information becomes availablethatmaybe relevantto the subject's willingness tocontinueparticipationinthe trial.
  • Theperson(s)tocontactforfurther information regarding thetrialandtherights oftrialsubjects, and whomto contactintheeventof trial-related injury.
  • Theforeseeablecircumstances and/orreasons under whichthe subject's participation inthe trialmaybe terminated.
  • Theexpected durationofthe subject's participationinthe trial.
  • Theapproximate numberofsubjectsinvolved inthetrial.

Yes No NAGCP 4.8.11 / As theinvestigator, you willensurethat, priorto participation in the research, the subjector the subject's legallyacceptable representative willreceivea copyofthe signed anddated consentformand anyotherwritteninformation provided tothe subject.Duringa subject's participation inthe research, the subjectorthesubject's legallyacceptable representative will receive a copyof thesigned and datedrevised consentformand a copyofanyupdates tothe written information provided to subjects.
Yes No NAGCP 4.8.12 / As theinvestigator, you willensurethatwhenresearch (therapeuticornon-therapeutic)includes subjects whocan only be enrolledintheresearchwiththe consentofthe subject's legallyacceptable representative (e.g., minors, orpatients with severe dementia), the subjectwillbe informed aboutthe research tothe extentcompatible withthe subject's understandingand,ifcapable,the subjectwillbegiven the opportunityto sign and personallydate the writteninformed consent.
Yes No NAGCP 4.8.13 / As theinvestigator, you willensurethat, exceptas described in
4.8.14 (below), non-therapeutic research(i.e., researchin which there is noanticipated directclinicalbenefittothesubject), will be conducted in subjects who personally give consentand who sign and datethe written informed consentform.
Yes No NAGCP 4.8.14 / Non-therapeuticresearch maybe conductedinsubjects with consentofalegallyacceptablerepresentative providedthe followingconditions are fulfilled:
•Theobjectives of the research cannotbe metbymeans ofresearchinsubjects whocan give informed consent personally.
•Theforeseeablerisks tothesubjects arelow.
•Thenegative impactonthesubject's well-beingis minimized and low.
•Theresearchis notprohibited bylaw.
•Theapprovalof the IRBis expresslysoughton the inclusion ofsuch subjects,and the IRB’s written approvalcoversthis aspect.
Such research,unlessan exceptionisjustified, willbe conductedin patients havinga disease orconditionforwhich theinvestigationalproductis intended.Subjects in these studies willbeparticularlycloselymonitored and willbe withdrawniftheyappeartobe undulydistressed.
Yes No NAGCP 4.8.15 / As theinvestigator, you willensurethatin emergency situations, when priorconsentof the subjectis notpossible,the consentof the subject's legallyacceptable representative, if present, willberequested.When priorconsentofthe subjectis notpossible, andthesubject's legallyacceptablerepresentative is notavailable,enrollmentof the subjectrequires measures described in the researchapplicationand/orelsewhere,with documented IRBapprovalto protect the rights,safety,and well-beingof the subjectand to ensure compliance withapplicableregulatoryrequirements.The subjectorthesubject's legallyacceptable representative willbe informed aboutthe
research assoonas possibleand consentto continue and otherconsentas appropriate(see4.8.10 above)willbe requested.
Records and Reports / Remarks
Yes No NAGCP 4.9.1 / As theinvestigator, you willensuretheaccuracy, completeness, legibility, and timeliness ofthe datareportedtothe sponsorin the CRFsand in allrequired reports.
Yes No NAGCP 4.9.2 / As theinvestigator, you willensurethatdatareported on the CRFderived fromsource documents are consistentwith the source documents. If thereare anydiscrepancies,theywill be/have been explained.
Yes No NAGCP 4.9.3 / As theinvestigator, you willensurethatanychange or correctiontoa CRF willbe/hasbeendated,initialed, and explained (ifnecessary)and willnot/does notobscurethe originalentry(i.e.,an audittrailshould be maintained). This appliesto both written andelectronic changes orcorrections. Sponsors shouldprovideguidance to investigatorsand/or the investigators'designatedrepresentatives on makingsuch corrections.Sponsors should have written procedures to assure thatchanges orcorrectionsin CRFs made bysponsor's designatedrepresentativesare documented,arenecessary, and are endorsed bythe investigator.Astheinvestigator,you will retainrecords ofthechanges and corrections.
Yes No NAGCP 4.9.4 / As theinvestigator, you will/do maintain researchdocuments as specifiedin EssentialDocuments forthe ConductofsClinical Trial(GCPsec. 8)and asrequired bytheapplicable regulatory requirement(s).You willtakemeasuresto preventaccidentalor prematuredestruction ofthese documents.
Yes No NAGCP 4.9.5 / As theinvestigator, you willensurethatessentialdocuments areretained untilatleast2 years afterthe lastapprovalofa marketingapplication oruntilat least2 years have elapsed since the formaldiscontinuation ofclinicaldevelopment ofthe investigationalproduct. Ifrequired bythe applicable regulatoryrequirements orbyan agreementwiththe sponsor, these documents maybe retainedforalongerperiod. It isthe sponsor’s responsibilitytoinformtheinvestigatorastowhen these documents nolongerneedto beretained.
Yes No NAGCP 4.9.6 / As theinvestigator, you willensurethatthefinancialaspects of the studyare documented in an agreementbetween yourselfand the sponsor.
Yes No NAGCP 4.9.7 / As theinvestigator, you willmake availablefordirectaccess all requested research-related records uponrequestof themonitor, auditor, IRB, orregulatoryauthority.
Progress Reports / Remarks
Yes No NAGCP 4.10.1 / As theinvestigator, you willsubmitwrittensummariesof the research statusto the IRBannually, ormore frequentlyif requested bythe IRB.
Yes No NAGCP 4.10.2 / As theinvestigator, you willpromptlyprovide writtenreports to the sponsor, the IRBand, whereapplicable, the institution on anychanges significantly affectingthe conductof the research, and/orincreasingrisks to subjects?
Safety Reporting / Remarks
Yes No NAGCP 4.11.1 / As theinvestigator, you will immediatelyreportallserious adverse events (SAEs)to the sponsor,exceptforthoseSAEs that the protocolorotherdocument(e.g., Investigator's Brochure)identifiesas notneedingimmediatereporting. The immediatereports willbe followed promptlybydetailed, writtenreports.The immediate and follow-up reportswill identifysubjects byuniquecode numbersassigned tothe research subjectsratherthan bythe subjects'names, personal identification numbers, and/oraddresses. You willalso comply withthe applicable regulatoryrequirement(s)related tothe reportingofunexpectedseriousadversedrugreactionsto the IRBand regulatoryauthority(ies).
Yes No NAGCP 4.11.2 / As theinvestigator, you willreportadverse events and/or laboratoryabnormalitiesidentifiedin the protocolascriticalto safetyevaluations, to the sponsoraccordingto the reporting requirementsand withinthe time periods specified bythe sponsorin the protocol.
Yes No NAGCP 4.11.3 / As theinvestigator, you willsupplythesponsorand the IRB with anyadditionalrequested information forreporteddeaths (e.g., autopsyreports andterminalmedicalreports).
PrematureTermination orSuspensionofa Trial / Remarks
Yes No NAGCP 4.12.1 / As theinvestigator, if the trialisprematurelyterminated or suspendedforanyreason, you willpromptlyinformthe subjects, assure appropriatetherapyand follow-up forthe subjects, and, where required bythe applicableregulatory requirement(s),informthe regulatoryauthority(ies).
Yes No NA AGCP 4.12.2 / As theinvestigator, ifyou terminateorsuspend research withoutprior agreementofthe sponsor, you willinformthe sponsorandthe IRB.Youwillprovidethe sponsorand the IRB with a detailed writtenexplanationofthetermination or suspension.
Yes No NAGCP 4.12.3 / If the sponsorterminates orsuspends atrial, you willpromptly informthe institution where applicable and you/institution will promptlyinformthe IRBand providea detailed written explanationofthetermination orsuspension.
Yes No NAGCP 4.12.4 / If the IRBterminates orsuspendsits approvalofyourresearch, you willinformthe institution whereapplicable and you/ institution willpromptlynotifythe sponsorandprovide the sponsorwith adetailed written explanationofthetermination orsuspension.
Final Report(s)by Investigator / Remarks
Yes No NAGCP 4.13.1 / Upon completion of the research, you will informthe IRBandprovide asummaryof the researchresults, and provideany reportsrequired bythe regulatoryauthority(ies).

PI name printed______