WIXLIB

GCP INSPECTION CHECKLIST(This list is not all inclusive; item may be added &/or deleted as per the Study/Site/Sponsor/Lab)I. General1.Name and address of theclinical trial site2.Date of InspectionInspection Team Members:3.4.Personnel present duringInspection (with name androle/designation.)5.Address & Contact details ofInvestigator:6.Name & address of the Sponsor7.Name & address of clinical trialNOC holder8.Name & address of EC9.Protocol Title10.Protocol NumberVersion/dateProtocol amendments, if any.11.Investigational Product

GCP INSPECTION CHECKLISTCentral Drugs Standard Control Organization12.Stage of study:(A) Before Trial Commencement(Mark the relevant)(B) During Conduct of the trial(C) After Completion of Trial13.Type of Inspection:SurveillanceFor CauseII.LEGAL & ADMINISTRATIVE ASPECTS:S. no.ItemYes1Clinical trial NOC from O/o DCGI(Note: mention along with Protocol no., Ver.,date)2NOC for subsequent protocol amendments,if any from O/o DCGI3Ethics Committee approval date(Note: mention along with Protocol no., Ver.,date)3Appendix VII as per Sch.-Y(mention revision(s) and notification to O/oDCGI, if any)4Whether valid financial agreement betweenthe Sponsor, Investigator & Institutionavailable.5Whether liability of(Investigator, Sponsorclearly agreed.6Is the valid clinical trial Insurance available?7Site Initiation dateDate of screening of first subject,89involved partiesand Institution)Date of signing ICF by the first subject10Date of Last Patient-Last Follow-Up (ifapplicable)11Whether SOP for various activities areestablished and documented.Page 2 of 10NoNARemark

GCP INSPECTION CHECKLISTCentral Drugs Standard Control Organization12Verify, whether the hospital/institute/site hasadequate emergency care facilities to handleemergency situation.III Organisation & Personnel1Assure that signed & dated, CurriculumVitae is available for the Investigator, SubInvestigator /Co-Investigator2Confirm the educational qualification of theInvestigator with registration by MedicalCouncil of State/India.3Confirm the GCP, Schedule Y and protocolspecific training of Investigator, SubInvestigator/Co-Investigator and its team.4Determine whether authority for conductingvarious clinical trial activities were delegatedproperly by Investigator to competentpersonnel (obtain the list of personnel andduty delegation log).5Check whether the person whom theauthority is delegated is adequately qualifiedand trained for the activity/activitiesassigned.6Obtain the list of all clinical trials performedby Investigator (Preferably for last threeyears)7Ensure that the Investigator is involved inconduct of not more than three clinical trialsat a time.IV Conduct of TrialA.Screening of subjects:1Check and review the informed consent forthe screening of the subjects.2Check site screening log & enrolment logand obtain authenticated copy.3Check whether the subjects are meeting the inclusion/exclusion criteria as per the approvedprotocol w.r.t review of source documents &/or CRF.3.1Clinical Examination by Investigator( Check patient file/Source documents)Page 3 of 10

GCP INSPECTION CHECKLISTCentral Drugs Standard Control Organization3.2Verify ,Clinical Laboratory Evaluation( Check Blood Cell Counts, Biochemicaltest, Urine analysis etc.as required byprotocol)3.3Verify X-Ray, MRI, ECG, USG or any othertechnique required to ascertain theinclusion/exclusion criteria.3.4Verify, Whether all conditions of Clinicaltrial NOC are followed or not?B. Subject record and Informed consent:123456789Whether ICF have all the elements enlistedin Appendix V of Schedule Y.Whether ICF is approved by EthicsCommittee prior to consent process.Whether IC has been obtained from eachsubject prior to participation of the subject inthe study.Whether signature/thumb impression of thesubjects/legal representative have beenaffixed with date.Whether in case of illiterate subjects orilliterate representative of a subject, there aresignature and details of an impartial witness.Have witness/ signature being personallydated.( If ally dated?Has the dated signature of the designatedperson for administering informed consent(IC) been affixed?Is the designated person for administering ICmedically qualified?If IC has been administered by a designatedperson who is not medically qualified, isthere evidence that subject's queries of amedical nature were answered by amedically qualified person or theinvestigator?Page 4 of 10

GCP INSPECTION CHECKLISTCentral Drugs Standard Control Organization10Is the completed ICF signed and dated by theinvestigator?11Check weather re-consenting is done forchanges in ICF, if any.B.112341234Audio-Visual recording of Informed Consent Process( For ‘vulnerable population’ in ‘NewChemical Entities (NCEs) clinical trial’ only & Anti HIV & Anti-Leprosy patients only Audiorecording) ( Verify as per GSR 611(E) dated 31.07.2015 )Whether audio-visual recording is performedfor all subjects, independently.Is audio-visual recording conducted in aroom conducive to recording of disturbancefree audio and video of the consent process?Check whether the video recording is freefrom disturbance to ensure that the image isrecognizable and the audio is clearly audible.Check whether the recording of informedconsent process is preserved safely.C. Source Documents and Case Record FormVerify condition, completeness, legibility,accessibility of the investigators source datafile. ( source data includes study subject’sfiles, recording from automated instruments,tracings, X-ray and other films, laboratorynotes, photograph negatives, magneticmedia, hospital records, clinical and officecharts, subject’s diaries, evaluation checklistsand pharmacy dispensing records)Whether subject received the test drug withrespect to dose and frequency according tothe protocol;Determine whether safety/ efficacy end pointdata( Clinical, laboratory examinationresults) were collected and reported inaccordance with the protocolDoes medical record mentions subject ID/name /hospital registration number / andindication that subjects are participating in aclinical trialPage 5 of 10

GCP INSPECTION CHECKLISTCentral Drugs Standard Control Organization56789Compare the source document with CRF anddetermine whether source data have beencorrectly transcribed in CRF;Verify the drop-outs and reason for drop-outof subject is appropriately recorded.Whether the withdrawal of subject from thestudy is recorded and appropriately justifiedin accordance with approved protocol.Verify whether Standard OperatingProcedure of handling of Serious AdverseEvent occurred in clinical trial is available.Verify whether all SAE’s have been reportedto the sponsor, EC and Licensing authority asper the timelines in accordance withSchedule Y.(Verify as per GSR 53(E) dated 30.01.2013& GSR 889 (E) dated 12.12.14 effectivefrom 12.06.2015 )1011121Verify Whether SOP for medical care duringserious adverse event is available or not.Verify whether adequate medical care havebeen given to the subject especially in theevent of inter current illness, adverse eventsincluding abnormal lab parameters;Verify whether all study related activities areperformed at site approved by O/o DCGI.VI. SponsorWhether investigator maintain copies of allreport submitted to the sponsor;2Whether all CRF were submitted to sponsorafter completion of study;3Determine whether all dropout and reasonthereof were reported to sponsor;4Determine the method and frequency ofmonitoring the progress of the study by thesponsor and corrective action by site.Page 6 of 10

GCP INSPECTION CHECKLISTCentral Drugs Standard Control Organization5Whether sponsor appointed a monitor withappropriate qualification and experience tomonitor trial at the site.6Whether a log of onsite monitoring visit ismaintained at the site.7Is monitor submits visit report withdeviations if any to the sponsor.89Whether sponsor performed an audit as a partof QA in order to independent and separatefrom routine monitoring of quality controlfunction.In case the investigator and sponsor agreesto prematurely terminate or suspend thestudy for any reason, whether it waspromptly informed to study subjects, EthicsCommittee and Licensing Authority.VII. Investigational Product1234567Review individual subject record to verifythe correct dose administration with respectto dose, frequency, route of administrationDetermine whether unqualified /unauthorisedpersons administered/dispensed the test drugDetermine whether adequate record ofquantity of test drug received , dispensed ismaintained.( Check the test drugreconciliation and verify the leftover drug orbalance on the day of inspection).Determine whether storagecondition/monitoring method are as perprotocol/recommendation;Whether trial medication are maintained insecured manner with controlled access;Have un-used trial medications been returnedto the sponsor or disposed of according toprotocol?Are the drugs dispensing records beingmaintained properly?Page 7 of 10

GCP INSPECTION CHECKLISTCentral Drugs Standard Control Organization8910Whether the records for reconciliation of allIP’s are maintained?Are electronic or hand-written temperaturelogs available for the storage area of theinvestigational products?Verify that investigation product isappropriately labelled. (For clinical trial useonly).VIII. Ethics Committee122Identify the name, address of the EC/ IEC inthe approval letter and compare it with onestated in Investigator Undertaking.Verify the Status of EC-whether Institutionalor Independent, Check Registrationcertificate ( Verify as per GSR 72(E) dated08.12.2013)Verify if EC approval letter mention studycode , title and version number of theprotocol, list of other documents reviewed,list of members present at the meeting,quorum of five members as specified inSchedule Y satisfied, date, time , venue ofthe meeting, signature and date of membersecretary / Chairman.3Verify whether the EC recorded minutes ofmeeting.4Verify whether EC is performed on sitemonitoring of the clinical trial approved.(Frequency and SOP)56Verify whether EC members have conflict ofinterest in the approved trial, if yes then themember should abstain from such approvalmeeting.Verify whether the communications betweenInvestigator and EC are available forchanges, Serious Adverse Event anddeviations occurred in clinical trial.Page 8 of 10

GCP INSPECTION CHECKLISTCentral Drugs Standard Control Organization7Verify whether EC is function in accordancewith conditions of registration by LA.IX Pathology Laboratory ( for Screening/ Assessment)Name and address of the clinical laboratory1used in the study. (Local and Outside).Whether financial & Confidentiality2agreement with Investigator and concernedlaboratory (ies) in place.3Is investigator/Sponsor verified theaccreditation status and adequacy of thefacilities to perform the specified tests as perprotocol.4Verify whether the SOP for samplepreparation, handling and transportation isavailable. Verify the appropriateness of theSOP.XQuality Assurance1Verify whether SOP for all proceduresconducted at site are availablei.e. have a copy of Site Specific and Trialspecific SOPs2Verify the essential components of SOP likewho prepared, checked, authorized andwhen, frequency of SOP revision3Whether SOPs for all operation likescreening and Informed consent Process, AVrecording of ICP of vulnerable population inNCE-CTs, SAEs & its Management,Communication with EC/Sponsor/CDSCO,GCP/Sch.Y, training to trial team, trainingassessment4Whether SOPs for all operation like IPhandling and distribution to study subjects,blood samples collection, processingpreservation and transportation to locallaboratory.5Whether SOPs for all operation of storagecabinets, refrigerators/deep freezers used tostore samples and IP are responsibilities, qualification andtraining for all personnel involved in theclinical trial is maintained and stored.Page 9 of 10