Bhaktivedanta Hospital Ethics Committee For Biomedical & Health Research Standard Operating Procedures Annexure 1 Bhaktivedanta Hospital Ethics Committee For Biomedical & Health Research Project by n Application Form for Initial Review © For observational studies sections 02, 05,06, 09, 10, 11, 12, 13, 17, 18, 19 would only be applicable. Tick \ in the box for the appropriate answer * Tick/ Write NA if question is not applicable Bhaktivedanta Hospital Ethics Committee For Biomedical & Health Research Protocol No. Title of the protocol Designation & Department & Qualifications Institution Signature Principal Investigator Co- Investigator Cor Investigator Version 01 dated 02 Sep 2019Standard Operating Procedures Bhaktivedanta Hospital Ethics Committee For Biomedical & Health Research Co- Investigator Co- Investigator Co- Investigator Coordinator (iF additional collaborators attach details and letter of Consent by the collaborator (ona separate page.) Please attach brief curriculum vitae of the study team members (Principal investigator, co- investigator, study coordinator) Yes LJ) No Non-sponsored (Investigator Initiated) Sponsored study [_] T.Sponsor Information = 1. Indian a) Government Central [|] State b) Private D International Government Private UN agencies 3. Industry National Multinational Contact Address of Sponsor: If sponsor is from out of India, contact address in India: ‘Version 01 dated 02 Sep 2019 Page 71Standard Operating Procedures Bhaktivedanta Hospital Ethics Committee For Biomedical & Health Research 2.Total Budget : Rs. Research Fund will be deposited in: | Other cov i, Does the study involve use of : Medicine /Vaccines/Device/Herbal Remedies : (Tick the appropriate boxes) Medicine Devices Vaceines Indian Systems of Medicine [] Any other NA If other, specify -~ ii, Is it approved and marketed In India UK & Europe [_] USA nal uuntries, specify Type of Study; Epidemiological [7] Basic Sciences Any Other Please specify. Clinical: Single center Muhtcentric If multicentric, how many centers : India and Globally (attach list of countries) 3. Clinieal Tri (Tick the appropriate box/option) Administration? Ifyes, whether DCGI’s /any other Regulatory authority’s Permis s obtained? Ifyes, Date of permission :---— iii, Does it involve a change in use, dosage, route of Yes |... Yes | No NA NA Version 01 dated 02 Sep 2019 Page 72Bhaktivedanta Hospital Ethics Committee For Biomedical & Health Research Standard Operating Procedures If No, whether DCGI's /Any other Regulatory Authority's Permission applied for? tei iv.is it an Investigational New Drug (IND)? Yes | No|NA If yes, IND No: a). Investigator’s Brochure submitted Yes | No|NA ). In vitro studies data Yes | No|NA ©), Pre clinical Studies done Yes | No|NA 4), Clinical Study is: Phase | Phase I _] Phase 11! [_] Phase IV Attached Yes No ©), To submit package insert in case test drug is already marketed in India 1D. Are you aware if this study/similar study is being done elsewhere ? If Yes, Specify details Yes No 2). Whether DCGI’s permission for testing IND Obtained? tyes, Date of permission Yes No [NA I) For Ayurvedic or herbal formulation, a copy of the marketing/manufacturing license issued by the FDA to the company to be submitted ‘Yes justi as attachment) |4. Protocol of the proposal — Introduction, review of literature, aim(s) & abjectives, ation for study, methodology describing the potential risks & benefits, outeome ‘measures, statistical analysis and whether it is of national significance with rationale( Submit Version 01 dated 02 Sep 2019 Page 73Standard Operating Procedures I Ethics Committee For Biomedical & Health Research 5. Research participants selection: Number of research participants at this centre : Number of research participants at other sites in India : Total number of research participants at all sites (in the world): Duration of study Will research participants from both sexes be Recruited? Yes_| No NA Inclusion / Exclusion eriteria given Yes_| No ‘Type of research participants Volunteers [_] Patients NA Vulnerable research participant Y| No NA Pregnant women Elderly/Geriatic 0 Mentally challenged Foetus O IliterateC Handicapped Children Captives Terminally/Seriously ill O | Students Dependent staff Institutionalized] Eeonomically/Socially Employees ‘Any Other a Backward Alene aa 6. Privacy and confidentiality i. Study involves - Direct Identifiers Indirect Identifiers/coded Completely anonymized/ delinked Confidential handling of data by staff Yes [No Version 01 dated 02 Sep 2019 Page 74Bhaktivedanta Hospital Ethies Committee For Biomedical & Health Research ‘Standard Operating Procedures 7. Use of biological/ hazardous materials Yes [No |NA i, Use of foetal tissue or abortus ii, Use of organs or body fluids Yes [No [NA ii, Use of pre-existing/stored/left over samples [Yes [No /NA iv. Use of Infectious/bio hazardous specimens Yes [No |NA v. Proper disposal of material Yes [No [NA 8. Will any sample collected from the patients. be sent abroad? | Yes | No | NA Ifno, test on samples be carried out: In hospital Outside hospital If outside BhaktiVedanta hospital and Research Institute , Address: 1a) Sample will be sent abroad because (Tick appropriate box): Facility not available in India Facility in India inaccessible Facility available but not being accessed. If so, reasons... b) Address: 9; Is the proposal being submitted for clearance from Health Ministry's Sereening Committee (HMSC) for International collaboration? (required in case of studies involving collaborations with foreign Laboratory/ Clinic/Institution) Yes No NA 10. In case of studies involving collaborations with other Indian or foreign Laboratory! Clinic/Institution has administrative sanction from the Managing director obtained/ applied for? NT ae ok tal tes SP: Page 75Bhaktivedanta Hospital Ethics Committee For Biomedical & Health Research Standard Operating Procedures Yes NA! 11, Consent : *Written Oral NA sual i. Consent form : (tick the included elements) Understandable language Statement that study involves research Sponsor of study Alternatives to participation Confidentiality of records Contact information Purpose and procedures, [7] Statement that consent is voluntary Risks & Discomforts Right to withdraw Benefits ‘Compensation for study related injury ‘Compensation for participation Benefits if any on future commercialization Consent for future use of biological material *[f written consent will not be obtained, give Whether applied for waiver of Consent: na (] NA reasons: Who will obtain consent? PUCo-PI Research staff Nurse/Counselor Any other participants? (posters, flyer, brochure, webs attach a copy) 12. Will any advertising be done for recruitment of research Yes: NA ites — if so kindly 13. Risks & Benefits: to research participants / community i, Is the risk reasonable compared to the anticipated benefits Yes | No / country? iii, social / psychological risk / discomfort If Yes, Minimal or no risk More than minimum risk Tsthere physical’ | Yes NA 1? Version 01 dated 02 Sep 2019 Page 76Bhaktivedanta Hospital Ethies Committee For Biomedical & Health Research Standard Operating Procedures High risk’ Is there a benefit (a) To the research participants? Direct Indirect (b) Benefit to society 14. Data Monitoring i. Isthere a data & safety monitoring committee/ Board (DSMB)? Yes No |NA ii. Is there a plan for reporting of adverse events? If Yes, reporting is done to : Yes [No | Sponsor Bhaktivedanta Hospitd__Jhics Comn{_ fe For Biomedical & Health Research DSMB iv. Is there a plan for interim analysis of data? Yes [No [NA v. Are there plans for storage and maintenance of all trial database? If Yes, for how long? - years Yes | No 15, Is there compensation for participation If Yes, Monetary In kind amount and type: Speci Yes [No [NA 16, Is there compensation for injury? IfYes, by Sponsor by Investigator by insurance by any other company Yes |No [NA 17. Do you have any conflict of interest in the present study? (finaneiaV/non financial) If Yes, specify Yes | No 18. Current Brief Curriculum Vitae (signed and dated copy) of the study team members- principal investigator, co-investigator and study coordinator (Information required age, designation and (To be enclosed along | with the form) | ry J Version 01 dated 02 Sep 2019 Page 77Bhaktivedanta Hospital Ethies Committee For Biomedical & Health Research Standard Operating Procedures ‘epariment, educational qualification, previous research experience | Yes in last five years) No (Information about GCP training of PI and co-investigator) 19. GCP training certificates of principal investigator and (To be enclosed along coordinator/s (mandatory only for drug and device trials not for with the form) ‘observational studies) le NO 20. Is the trial registered with Clinical Trial Registry? (mandatory | Yes |No | NA only for drug trials) Clinical Trial Registry of India(CTRD/ any other WHO platform registry, Registration number: If not registered, state the reason, Statement of Complian We hereby declare that the information given above is true and that we will comply with the guidelines mentioned in the Schedule Y (Drugs and Cosmetic Act 1940; amendment 20" ‘Tanuary 2005), Ethical Guidelines for Biomedical Research on Human Participants by Indian Couneil of Medical Research (2006). We also ensure that Principal Investigator / Institution will pay for treatment and / or compensation if study related injury occurred due to protocol violation by PI / study team. Signature of Principal Investigator with date: Signature/s with date of Co-investigators: ‘Version 01 dated 02 Sep 2019 Page 78Bhaktivedanta Hospital Ethies Committee For Biomedical & Health Research Annexure 2 Standard Operating Procedures Check List for Protocol Submission Check List of Documents for Protocol Submission to the Bhaktivedanta Hospital Ethics Committee For Biomedical & Health Research to be filled in by the study team Protocol submission for initial review (Tick accordingly; compulsory documents have to be submitted by ticking in the box marked as Yes’) * Compulsory documents for initial review Sr. | Document Yes | No | Date by which it will | NA be submitted, if No. " pending ‘T__| *Project submission application form duly filled 2 | *Letter to Member Secretary/ Chairpersor e 3 __ | Protocol Synopsis (For Clinical Trials) 4 *Protocol 3 | Minformed consent document in English *Informed consent documents in Regional languages (Total No:~ ) 7 | *Case Record Form ra 8 | *Research participants recruitment procedures: | advertisement, notices (If applicable) 9 | *Patient instruction card, identity card, diary ete. ao (If applicable) 10 | *Research participants Questionnaire/s (If | applicable) 11 | “investigator Brochure (If applicable) 12 | *Insurance certificate and policy (If applicable) Version 01 dated 02 Sep 2019 Page 79Bhaktivedanta Hospital Ethies Committee For Biomedical & Health Researeh Standard Operating Procedures 13 _| “investigator's undertaking to DCG() (If eomiaieaees applicable) 14 | DCGO) approval (Only one copy is needed for submission)[if DCGI approval is awaited, the same is mentioned in the covering letter to the Bhaktivedanta Hospital Ethics Committee For Biomedical & Health Research] 15 | *Clinical Trial Agreement for drug trial Memorandum Of Understanding, as applicable, for other trials (draft if final not ready) 16 | FDA marketing/manufacturing license for herbal | formulations/ nutraceutics( Only one copy is | needed for submission) 17 _ | *Signed and dated brief current curriculum vitae of the study team members (principal estigator, co-investigator, study co- coordinator) (one copy only) 18 | *Log of delegation of responsibility of the study a team members. - Sample Format Enclosed) 19 | Documentation of CTRI registration’ any other WHO platform registry (whenever applicable) (one copy only ) FE 20 *GCP training certificates of Principal investigator 21 | Any other Documents submitted a tte een Version 01 dated 02 Sep 2019 Page 80; Bhaktivedanta Hospital Ethics Committee For Biomedical & Health Research | Standard Operating Procedures Annexure 3 D. n of Responsibilities o' team Bhaktivedanta Hospital Ethics Committee For Biomedical & Health Research Protocol No. Study Title ‘Name Role No. Principal Investigator [1 Co-Investigator 2 a Co-Investigator 3 | Co-investigator 4 Study coordinator * 3 Laboratory Technician | 6 * Study coordinator may preferably be a person specifically appointed for coordinating the clinical trial; other than the staff member (Please place tick marks against assigned duties for each member in the following table) Cod [TASKS Role | Role | Role | Role4 | Role | Role e 1 2: 3 5 \6 ‘A__ | Allzelevant documents pertaining to protect blinding B__ | Research participants selection/ Screening CT ee Version 01 dated 02 Sep 2019 Page 81Bhaktivedanta Hospital Ethics Committee For Biomedical & Health Research Standard Operating Procedures [C | Obtain informed consent D__ | Evaluate inclusion/ exclusion criteria E | Conduct the visit assessments F | Physical examination G | Complete the source documents [TH | Complete Case Record Form 7 Final review and sign Case Record Form J | Collect laboratory safety test samples K _| Processing of blood samples Preparing aliquots & Keeping a track of the samples sent M__ | Review & sign of the lab reports N__ | Receive the study drug, , document drug dispensing, storage & accountability | © | Person to whom research participants should contact in ease of adverse event P Report all serious adverse events Q _| Follow up of Serious Adverse Event Bi Maintaining study site master file S___| in-charge of inventory & supplies 7 Archiving of study documents a U__| Resolution of queries V__ | Overall coordination and supervision Version 01 dated 02 Sep 2019 Page 82