{"id":1987,"title":"PROPOSAL FORM - CLINICAL TRIALS LIABILITY INSURANCE","purpose":"proposal","insurer":{"slug":"icici-lombard-general-insurance","name":"ICICI LOMBARD General Insurance Company Limited"},"source_pdf":"https://www.icicilombard.com/docs/default-source/default-document-library/4-clinical-trials-liability-insurance-commercial8c0007ff45fd68ff8a0df0055fa612e2.pdf","sha256":"1055c88d5fb623010e4171035ffdfc5f8d7cfc558b79ec7c4b0f6de8c3e9aaae","pages":4,"collected":"2026-10-20","instructions":{"about":"This form is a proposal for Clinical Trials Liability Insurance to be filled by the proposed policyholder seeking insurance coverage for clinical trials liability risks.","notes":["Answer all questions completely and correctly; write 'Not Applicable' if a question does not apply.","Proposal must be signed, stamped, and dated by an authorized signatory.","Insurance contract is based on utmost good faith; disclose all material facts.","Attach additional sheets if more space is needed, indicating question number.","Use the policyholder’s bank account details and attach a cancelled cheque for EFT claim processing.","Statutory warning on prohibition of rebates under Section 41 of Insurance Act 1938 applies."],"title":"PROPOSAL FORM - CLINICAL TRIALS LIABILITY INSURANCE","submit":{"to":"","how":"","address":""},"purpose":"proposal","sections":[{"title":"Company and Product Information","fields":[{"help":"Enter the full name and address of the company proposing insurance.","type":"text","label":"Company Name and Address:","options":[],"required":null,"pdf_field":""},{"help":"Provide details about the product involved in the clinical trial.","type":"text","label":"Product Information:","options":[],"required":null,"pdf_field":""},{"help":"Describe the product for which the clinical trial is conducted.","type":"text","label":"Product Description:","options":[],"required":null,"pdf_field":""},{"help":"Provide demographic and health details of the trial participants.","type":"text","label":"Profile of probands: age, sex, race, health status, co-medication","options":[],"required":null,"pdf_field":""},{"help":"Summarize potential hazards and risk mitigation plans.","type":"text","label":"Summary of hazards identified or anticipated, their causes and associated risks, and proposed mitigating action:","options":[],"required":null,"pdf_field":""},{"help":"Describe the manufacturing process of the product.","type":"text","label":"Manufacturing Process:","options":[],"required":null,"pdf_field":""},{"help":"Mention if the product is registered in any other country.","type":"text","label":"Any registration for this product in another country already:","options":[],"required":null,"pdf_field":""},{"help":"Describe the intended use of the product in the trial.","type":"text","label":"Description of Intended Use:","options":[],"required":null,"pdf_field":""},{"help":"Provide dose, dosage form, and route of administration.","type":"text","label":"Dose/ Dosage Form / Roa:","options":[],"required":null,"pdf_field":""},{"help":"Describe the study population for the clinical trial.","type":"text","label":"Study Population:","options":[],"required":null,"pdf_field":""},{"help":"Specify the observation period for the trial.","type":"text","label":"Observation Period:","options":[],"required":null,"pdf_field":""},{"help":"State the efficacy endpoints of the trial.","type":"text","label":"Efficacy End Point:","options":[],"required":null,"pdf_field":""},{"help":"Enter the number of participants in the trial.","type":"number","label":"Probands How many probands will participate?","options":[],"required":null,"pdf_field":""},{"help":"List the inclusion criteria for participants.","type":"text","label":"Inclusion Criteria:","options":[],"required":null,"pdf_field":""},{"help":"List the exclusion criteria for participants.","type":"text","label":"Exclusion Criteria:","options":[],"required":null,"pdf_field":""},{"help":"Provide data from past or other trials for the product.","type":"text","label":"Past/ Other Trial data for this product:","options":[],"required":null,"pdf_field":""},{"help":"Provide details if answered Yes above.","type":"text","label":"If yes, please give details (Nature of relationship and position held by PEP):","options":[],"required":null,"pdf_field":""}],"filled_by":"proposed policyholder"},{"title":"Background and Trial Details","fields":[{"help":"Summarize previous clinical investigations or research.","type":"text","label":"Brief summary of all applicable clinical investigations or research conducted by the sponsor","options":[],"required":null,"pdf_field":""},{"help":"Describe planned pre-clinical and clinical activities.","type":"text","label":"Summary of Planned Major Pre-clinical And Clinical Activities","options":[],"required":null,"pdf_field":""},{"help":"Provide the time schedule for the trial.","type":"text","label":"Time-Schedule for the trial","options":[],"required":null,"pdf_field":""},{"help":"Enter the protocol number of the trial.","type":"text","label":"Protocol Number:","options":[],"required":null,"pdf_field":""},{"help":"Explain the need for the study.","type":"text","label":"Need For The Study","options":[],"required":null,"pdf_field":""},{"help":"Provide the title of the study.","type":"text","label":"Study Title","options":[],"required":null,"pdf_field":""},{"help":"Name the investigational drug used.","type":"text","label":"Investigational Drug","options":[],"required":null,"pdf_field":""},{"help":"Provide dose, dosage form, and route of administration.","type":"text","label":"Dose/ Dosage Form/Roa:","options":[],"required":null,"pdf_field":""},{"help":"Describe the study population.","type":"text","label":"Study Population:","options":[],"required":null,"pdf_field":""},{"help":"Enter the sample size for the trial.","type":"number","label":"Sample Size:","options":[],"required":null,"pdf_field":""},{"help":"Specify the clinical phase of the trial.","type":"text","label":"Clinical Phase:","options":[],"required":null,"pdf_field":""},{"help":"State the objective of the trial.","type":"text","label":"Objective","options":[],"required":null,"pdf_field":""},{"help":"List the efficacy endpoints.","type":"text","label":"Efficacy Endpoints :","options":[],"required":null,"pdf_field":""},{"help":"Describe safety measurements planned.","type":"text","label":"Safety Measurements","options":[],"required":null,"pdf_field":""},{"help":"Provide the rationale for the study.","type":"text","label":"Rationale","options":[],"required":null,"pdf_field":""},{"help":"Describe the data analysis plan.","type":"text","label":"Data Analysis","options":[],"required":null,"pdf_field":""},{"help":"List tests and examinations planned during the trial.","type":"text","label":"Details of each test as well as the purpose. Examinations planned during the trial (eg. blood parameters, x-ray…)","options":[],"required":null,"pdf_field":""},{"help":"Specify primary tests or endpoints.","type":"text","label":"Primary:","options":[],"required":null,"pdf_field":""},{"help":"Provide an outline of feasibility and evaluation protocols.","type":"text","label":"Outline of planned feasibility and clinical evaluation protocols","options":[],"required":null,"pdf_field":""},{"help":"Specify the jurisdiction for the policy.","type":"text","label":"Jurisdiction:","options":[],"required":null,"pdf_field":""},{"help":"Describe the coverage required under the policy.","type":"text","label":"Coverage Required:","options":[],"required":null,"pdf_field":""},{"help":"Provide details of resources for protocol development.","type":"text","label":"Protocol Development Resources:","options":[],"required":null,"pdf_field":""},{"help":"Specify the territorial scope of the insurance cover.","type":"text","label":"Territorial Scope of cover:","options":[],"required":null,"pdf_field":""},{"help":"Enter the aggregate limit of liability per year in INR.","type":"amount","label":"Limit of Liability Aggregate AOY: INR","options":[],"required":null,"pdf_field":""},{"help":"Enter the limit per accident in INR.","type":"amount","label":"Any one Accident Limit AOA: INR","options":[],"required":null,"pdf_field":""},{"help":"Enter the limit per volunteer or subject in INR.","type":"amount","label":"Limit Per volunteer/Subject: INR","options":[],"required":null,"pdf_field":""},{"help":"Enter the start and end dates of the policy period.","type":"date","label":"Policy Period: From:  D D / M M / Y Y Y Y To :  D D / M M / Y Y Y Y","options":[],"required":null,"pdf_field":""},{"help":"Select Yes or No and provide details if Yes.","type":"choice","label":"Are you aware of any such event/situation/accident that can lead to Clinical Trials/BE Study Liability Claim? NO YES (incase of Yes, please provide full details)","options":["NO","YES"],"required":null,"pdf_field":""}],"filled_by":"proposed policyholder"},{"title":"Additional Details and Bank Account Information","fields":[{"help":"Answer Yes or No for compliance with listed guidelines.","type":"yes-no","label":"1) Are all trials/studies in full accordance with: a) Department of health requirements with protocols approved by an independent ethics committee? b) Royal College of Physicians recommendations? c) Applicable Government Department or Medical Body or Pharmaceutical Industry Body Guidelines? d) ICH Guidelines on Good Clinical Practice","options":[],"required":null,"pdf_field":""},{"help":"Specify if trials are conducted outside India and provide summaries.","type":"text","label":"2) Are all trials/studies conducted in India? If not show summaries of trials in each country","options":[],"required":null,"pdf_field":""},{"help":"Answer Yes or No regarding rights of recourse.","type":"yes-no","label":"3) If applicable, are all rights of recourse retained against product manufacturers?","options":[],"required":null,"pdf_field":""},{"help":"Answer Yes or No about testing volunteers for HIV and Hepatitis.","type":"yes-no","label":"4) Are all volunteers tested for HIV and Hepatitis prior to entering trial?","options":[],"required":null,"pdf_field":""},{"help":"Provide details of any such incidents in last 5 years.","type":"text","label":"5) Details of incidents during the last 5 years resulting in death injury, disease or illness to patients or volunteers or any circumstances, which might give, rise to claim for compensation.","options":[],"required":null,"pdf_field":""},{"help":"Summarize trials/studies performed in last 12 months.","type":"text","label":"6) Summary of trial/studies performed in the last twelve months: Date commenced, Title/description, country, phase, Number of volunteers.","options":[],"required":null,"pdf_field":""},{"help":"Provide pre-clinical supporting data.","type":"text","label":"Pre-clinical supporting data","options":[],"required":null,"pdf_field":""},{"help":"Provide quality assurance details.","type":"text","label":"Quality Assurance","options":[],"required":null,"pdf_field":""},{"help":"Provide analysis of the study.","type":"text","label":"Analysis Of The Study","options":[],"required":null,"pdf_field":""},{"help":"Enter the name as per bank records.","type":"text","label":"Proposed policyholder’s name (as per bank record):","options":[],"required":true,"pdf_field":""},{"help":"Enter the bank account number.","type":"text","label":"Proposed policyholder’s account no.:","options":[],"required":true,"pdf_field":""},{"help":"Enter the bank name.","type":"text","label":"Name of Bank","options":[],"required":true,"pdf_field":""},{"help":"Enter the bank's address.","type":"text","label":"Address of the bank:","options":[],"required":true,"pdf_field":""},{"help":"Enter the bank branch.","type":"text","label":"Branch","options":[],"required":true,"pdf_field":""},{"help":"Enter the 9-digit MICR code.","type":"text","label":"MICR Code (9 digit)","options":[],"required":true,"pdf_field":""},{"help":"Enter the PAN card number.","type":"text","label":"PAN card no. of the proposed policyholder:","options":[],"required":true,"pdf_field":""},{"help":"Enter the 11-digit IFSC code.","type":"text","label":"IFSC Code (11 digit)","options":[],"required":true,"pdf_field":""}],"filled_by":"proposed policyholder"},{"title":"Documents to be attached","fields":[{"help":"Attach the following documents: Copy of Study protocol, Specimen copy of Informed Consent form, Specimen copy of SADR reporting form (serious adverse drug reaction), Specimen copy of Sponsorer's contract with other parties involved in the trials (e.g. CRO etc.), Specimen of case record form.","type":"attachment","label":"Documents to be attached with proposal form","options":[],"required":true,"pdf_field":""}],"filled_by":"proposed policyholder"},{"title":"Declaration by Proposed Policyholder","fields":[{"help":"Enter the place of signing.","type":"text","label":"Place :","options":[],"required":null,"pdf_field":""},{"help":"Sign the proposal form.","type":"signature","label":"Proposers Signature","options":[],"required":true,"pdf_field":""},{"help":"Enter the name of the signatory.","type":"text","label":"Name:","options":[],"required":true,"pdf_field":""},{"help":"Enter the designation of the signatory.","type":"text","label":"Designation","options":[],"required":true,"pdf_field":""}],"filled_by":"proposed policyholder"}],"deadlines":[],"applies_to":"Clinical Trials Liability Insurance","attachments":["Copy of Study protocol","Specimen copy of Informed Consent form","Specimen copy of SADR reporting form (serious adverse drug reaction)","Specimen copy of Sponsorer's contract with other parties involved in the trials (e.g. CRO etc.)","Specimen of case record form","Cancelled cheque of the policyholder’s bank account"],"declarations":["Consent to verify identity/address proof through Central KYC Registry or UIDAI or other modes for KYC.","Premium has been paid from legally acquired sources and future premiums will be paid similarly.","Authorization to share personal and financial information with ICICI Bank Group companies and agents.","Policy shall be voidable if any untrue, incorrect, or incomplete statement or non-disclosure is made.","The proposal and declarations form the basis of the contract and will be incorporated into the policy.","Policy issuance and cover commencement are subject to realization of premium cheque.","If premium collected is less than quoted, policy will be issued for reduced sum accordingly.","Company may call for documents to establish source of funds.","Details furnished are true and correct and any changes will be informed within 30 days.","False or misleading information may lead to liability."],"dropped_labels":2},"pdf_fields":null,"fillable_pdf":false,"send_to":[],"how_to_use":"Ask the user for each field in order, in plain words; never invent an answer. Labels are as printed. If fillable_pdf is true, pdf_fields gives the PDF's own field names so the file can be filled directly. The printed form decides if anything differs.","url":"https://indiainsurances.com/forms/icici-lombard-general-insurance/1987-proposal-form-clinical-trials-liability-insurance"}