{"id":467,"title":"Claim Reporting Form - Clinical Trials Liability Insurance","purpose":"claim","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/clinical-trials-liability---retail.pdf","sha256":"9e61dff3aa44e7c922f217e3e141e5f5300e45899cbb33c5b15a5a080be48c58","pages":4,"collected":"2026-10-20","instructions":{"about":"This form is used by the insured to report adverse events occurring during a clinical trial under the Clinical Trials Liability Insurance policy.","notes":["Comments on incident description should be factual and objective; unknown aspects should be recorded as allegations or possibilities","Any action taken listed as 'medication' or 'other' must be described in detail","In case of third-party property damage or bodily injury, file an FIR if applicable as per policy terms","Claim intimation can be done via toll-free number, email, or website claim portal","Surveyor will be appointed within 24 hours of claim reporting based on eligibility","Assessment report will be furnished within 15 days of receipt of claim form and documents","Claim decision will be made within 7 days of receipt of assessment report","Use original documents and provide all necessary supporting documents as listed","Photographs or videos of damaged property/item under claim may be required","KYC and NEFT details must be provided as per AML guidelines"],"title":"Claim Reporting Form - Clinical Trials Liability Insurance","submit":{"to":"Assigned Claims Service Manager (CSM) or Surveyor","how":"Submit documents to the assigned CSM/Surveyor","address":""},"purpose":"claim","sections":[{"title":"1. Insured details","fields":[{"help":"","type":"text","label":"Policy no.","options":[],"required":null,"pdf_field":""},{"help":"","type":"phone","label":"Telephone number:","options":[],"required":null,"pdf_field":""},{"help":"","type":"text","label":"Address:","options":[],"required":null,"pdf_field":""},{"help":"","type":"text","label":"Name:","options":[],"required":null,"pdf_field":""},{"help":"","type":"email","label":"E-mail id:","options":[],"required":null,"pdf_field":""},{"help":"Format: Date - Month - Year","type":"date","label":"Expiry date:","options":[],"required":null,"pdf_field":""},{"help":"Format: Date - Month - Year","type":"date","label":"Retro date:","options":[],"required":null,"pdf_field":""}],"filled_by":"insured"},{"title":"2. Details of the trial in respect of which the adverse event reported","fields":[{"help":"","type":"text","label":"Principal Investigator:","options":[],"required":null,"pdf_field":""},{"help":"","type":"text","label":"Protocol Title:","options":[],"required":null,"pdf_field":""},{"help":"","type":"text","label":"Protocol Number:","options":[],"required":null,"pdf_field":""},{"help":"Format: Date - Month - Year","type":"date","label":"Date of Event:","options":[],"required":null,"pdf_field":""}],"filled_by":"insured"},{"title":"3. Details of the ‘study subject’","fields":[{"help":"Enter the number of subjects affected by the adverse event","type":"number","label":"Number of subjects affected:","options":[],"required":null,"pdf_field":""},{"help":"Enter the total number of subjects who received the trial drug","type":"number","label":"Number of subjects administered the trial drug:","options":[],"required":null,"pdf_field":""},{"help":"Full name of the patient affected","type":"text","label":"Name of the patient:","options":[],"required":null,"pdf_field":""},{"help":"Full address of the patient","type":"text","label":"Complete address of the patient:","options":[],"required":null,"pdf_field":""},{"help":"Enter age and sex of the patient","type":"text","label":"Age & sex:","options":[],"required":null,"pdf_field":""},{"help":"Patient's medical record number","type":"text","label":"Medical Record number","options":[],"required":null,"pdf_field":""}],"filled_by":"insured"},{"title":"4. Was the possibility of the event addressed in the protocol and consent?","fields":[{"help":"","type":"checkbox","label":"Yes","options":[],"required":null,"pdf_field":""},{"help":"","type":"checkbox","label":"No","options":[],"required":null,"pdf_field":""}],"filled_by":"insured"},{"title":"5. Please check one category: The adverse event was:","fields":[{"help":"Select if the event is highly related","type":"checkbox","label":"a. Highly related to the drug or device","options":[],"required":null,"pdf_field":""},{"help":"Select if the event is likely related","type":"checkbox","label":"b. Likely related to the drug or device","options":[],"required":null,"pdf_field":""},{"help":"Select if the event is unrelated","type":"checkbox","label":"c. Unrelated to the drug or device","options":[],"required":null,"pdf_field":""},{"help":"Select if the event is possibly related","type":"checkbox","label":"d. Possibly related to the drug or device","options":[],"required":null,"pdf_field":""},{"help":"Select if relationship is unknown","type":"checkbox","label":"e. Relationship to drug or device unknown","options":[],"required":null,"pdf_field":""}],"filled_by":"insured"},{"title":"6. Should the consent form be modified?","fields":[{"help":"If yes, attach a revised copy of the consent form","type":"checkbox","label":"Yes","options":[],"required":null,"pdf_field":""},{"help":"","type":"checkbox","label":"No","options":[],"required":null,"pdf_field":""}],"filled_by":"insured"},{"title":"PEP Declaration","fields":[{"help":"PEP means Politically Exposed Persons as defined on the form","type":"yes-no","label":"Are you or any of the proposed applicants/beneficial owner a PEP* or Family member/Close relatives/Associates of PEP*?","options":["Yes","No"],"required":null,"pdf_field":""},{"help":"Describe the relationship and position held","type":"text","label":"If yes, please give details (Nature of relationship and position held by PEP):","options":[],"required":false,"pdf_field":""}],"filled_by":"insured"},{"title":"8. Are any protocol revisions required?","fields":[{"help":"If yes, attach a description of the proposed changes","type":"checkbox","label":"Yes","options":[],"required":null,"pdf_field":""},{"help":"","type":"checkbox","label":"No","options":[],"required":null,"pdf_field":""}],"filled_by":"insured"},{"title":"9. Action - study drug / device was:","fields":[{"help":"Select if drug/device dose was reduced","type":"checkbox","label":"a. Reduced","options":[],"required":null,"pdf_field":""},{"help":"Select if drug/device was stopped temporarily","type":"checkbox","label":"b. Stopped temporarily","options":[],"required":null,"pdf_field":""},{"help":"Select if drug/device was permanently discontinued","type":"checkbox","label":"c. Permanently discontinued","options":[],"required":null,"pdf_field":""},{"help":"Select if no action was necessary","type":"checkbox","label":"d. No action necessary","options":[],"required":null,"pdf_field":""}],"filled_by":"insured"},{"title":"10. Details of the incident/event","fields":[{"help":"Type of incident","type":"text","label":"a. Incident Type:","options":[],"required":null,"pdf_field":""},{"help":"Format: Date - Month - Year","type":"date","label":"b. Date of Incident:","options":[],"required":null,"pdf_field":""},{"help":"Format: Date - Month - Year","type":"date","label":"c. Date Reported:","options":[],"required":null,"pdf_field":""},{"help":"Region where incident occurred","type":"text","label":"d. Incident Region:","options":[],"required":null,"pdf_field":""},{"help":"Specific location of incident","type":"text","label":"e. Incident location:","options":[],"required":null,"pdf_field":""},{"help":"Name(s) of witness(es)","type":"text","label":"f. Witness:","options":[],"required":null,"pdf_field":""},{"help":"Name of injured or claimant","type":"text","label":"g. Injured Person or Potential Claimant:","options":[],"required":null,"pdf_field":""},{"help":"Provide a factual and objective description of the incident","type":"text","label":"h. Incident Description*:","options":[],"required":null,"pdf_field":""},{"help":"Cause as alleged or possible","type":"text","label":"i. Alleged Cause:","options":[],"required":null,"pdf_field":""},{"help":"Actions taken to remedy the incident","type":"text","label":"j. Remedial Action:","options":[],"required":null,"pdf_field":""},{"help":"Date remedial action was completed","type":"date","label":"k. Date Completed:","options":[],"required":null,"pdf_field":""},{"help":"Cost incurred due to incident","type":"amount","label":"l. Cost of Incident:","options":[],"required":null,"pdf_field":""},{"help":"Name of person reporting the incident","type":"text","label":"m. Reporter's Name:","options":[],"required":null,"pdf_field":""},{"help":"Phone number of reporter","type":"phone","label":"n. Reporter's Phone:","options":[],"required":null,"pdf_field":""},{"help":"Describe how the serious adverse event was discovered","type":"text","label":"o. How was SAE discovered (e.g. new, routine exam, follow-up)?","options":[],"required":null,"pdf_field":""}],"filled_by":"insured"},{"title":"Signature and Declaration","fields":[{"help":"Sign the form","type":"signature","label":"Signature of the insured:","options":[],"required":true,"pdf_field":""},{"help":"Date of signing (Date - Month - Year)","type":"date","label":"Date:","options":[],"required":true,"pdf_field":""},{"help":"Name of the signatory","type":"text","label":"Name:","options":[],"required":true,"pdf_field":""},{"help":"Designation of the signatory","type":"text","label":"Designation:","options":[],"required":null,"pdf_field":""}],"filled_by":"insured"}],"deadlines":["All Non-fatal, serious adverse events must be reported within 24 hours of knowledge","Serious adverse events (SAEs) are to be reported within seven (7) days or an explanation must be provided"],"applies_to":"Clinical Trials Liability Insurance (Retail)","attachments":["Brief description of the adverse event, actions taken and the outcome","Copies of sponsor reports","Informed consent forms signed by subjects","Trial Protocol document","Copy of GCP guidelines","If consent form is modified, a revised copy of the consent form","Description of proposed protocol revisions if any"],"declarations":["The information given in this claim form is true, correct and complete","All persons having an interest in the property are disclosed as per the proposal or policy endorsement","No similar claim has been made with any other insurance company except as disclosed","No material information relevant to the claim has been withheld or not disclosed","If any false or fraudulent information is given, the policy shall be void and no claim rights will exist","Receipt of this claim form or documents does not constitute admission of claim by the company","Consent is given to the company to verify identity/address proof through Central KYC Registry or UIDAI or other modes for KYC purposes"],"dropped_labels":5},"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/467-claim-reporting-form-clinical-trials-liability-insurance"}