The trial can be initiated (begin screening and/or enrolment of trial subjects) only after the Clinical Monitor has satisfactorily conducted a Trial Initiation Monitoring Visit and the TDR Clinical Coordinator has given written authorization.
Investigator’s File, Including Storage and Retention
On initiation of the study, the Investigator must prepare a file containing documents related to the trial. During the study, the Investigator is responsible for updating the File and regularly adding trial-related documents.
The Investigator should keep the File in a locked cabinet, in a secure area accessible only to the Investigator and authorized study staff. The Investigator File and associated source documents should be retained for the time agreed with TDR/sponsors. Patient identification codes should be kept for at least 15 years after completion of the trial. Written approval from sponsors must be obtained prior to destroying records.
The Investigator's File contains:
Ø Administrative and Regulatory Documents
Ø Composition of IEC/IRB.
Ø Local regulatory requirements.
Ø IEC/IRB and other authorities’ written approval for all documents (protocol, informed consent(s) and any written information including advertisements for recruitment of study subjects).
Ø IEC/IRB and other authorities’ written approval for protocol amendments.
Ø Correspondence with the Ethics Committee and the Authorities, including:
· Protocol submission.
· Amendment submission, if any.
· Protocol modification notification, if any.
· Interim report/written summaries of the trial, if applicable.
· Final Report/written summaries of the trial, if applicable.
· Product importation authorization.
Ø Correspondence about product importation.
Ø For studies under IND, a copy of the completed and signed Form FDA 1572.
Ø Investigator’ s and Co/Sub-investigators’ C.V.s
Ø New Investigator and Sub-investigators’ C.V.s, if appropriate.
Ø Authorized Staff Form (ASF).
Ø Technical Services Agreement (TSA) signed/dated by both parties.
Ø Signed confidentiality agreement.
Ø Signed agreement stating that products will not be used before the Trial Initiation
Ø Monitoring Visit has been made and approval from the TDR Clinical Coordinator obtained.
Ø Copy of the insurance certificate/other insurance.
Ø ICH GCP guideline.
Ø TDR/TDP investigator’ s SOPs.
Ø Study Archiving Form (copy).
Ø Copy of the Investigator's interim report/written summaries of the trial to the IEC/IRB and authorities, if applicable.
Ø Copy of the Investigator's final report/written summaries of the trial to the IEC/IRB and authorities, if applicable.
Correspondence and Monitoring
Ø Correspondence with TDR/sponsoring agencies (including the telephone call, E-mail etc).
Ø Notes of meetings with TDR/sponsoring agencies.
Ø Summary list of site visits (copy).
Ø Trial Initiation Monitoring Report (copy).
Ø Notification by Investigator to TDR/Sponsor of serious adverse event and related reports.
Ø Documentation of serious adverse event reporting by TDR/Sponsor to other investigators.
Ø Correspondence about important requests.
Ø Investigator interim report/summaries of the trial for TDR/sponsoring agencies, if applicable.
Ø Investigator final report/summary of the trial for TDR/sponsoring agencies, if applicable.
Trial Documents
Ø General documents
Ø Investigator’ s brochure, with updates, if any
Ø Approved protocol and amendments, signed and dated by the Investigator(s) and sponsoring agencies, and new protocol amendments, if any.
Ø Approved informed consent and any other written information including all translations, and advertisements for recruitment of study subjects.
Ø Informed consent procedure.
Ø Clinical Trial Final Report (if available during the Study Closeout Visit).
Data reporting
Ø Blank CRF.
Ø Blank SAE/UAE forms.
Ø Blank source document if not existing on site.
Ø Case Report Form completion procedure.
Ø Adverse event reporting procedure.
Ø Blank screening and enrolment log.
Product
Ø Product certificate/batch release.
Ø Certificate of extension of the batch expiry date, if applicable.
Ø Dispatch notes (original) and acknowledgement of receipt (copy) (in case of new delivery).
Ø Randomization list/envelope or acknowledgement of receipt.
Ø Randomization list/envelope or randomization list/envelope retrieval certificate.
Ø Code Breaking list/randomization envelope retrieval certificate.
Ø Subject assignment list.
Ø Product management procedure.
Ø Product exportation/importation authorization
Ø Product accountability log.
Ø Product management form.
Ø Return of unused products form, or product destruction certificate if destroyed on site.
Ø Temperature recording log, if appropriate (especially for vaccines/biologicals).
Ø Other products-related trial documents.
Laboratory specimens.
Ø Laboratory certification/normal ranges/update of normal values.
Ø Reactive dispatch note and acknowledgement of receipt.
Ø Specimen management procedures (collection, performing assay, storage, results).
Ø Subject specimen collection log.
Ø Shipment note, if appropriate.
Ø Temperature recording log, if appropriate (deep frozen samples).
Ø Record of retained laboratory specimens, if any, to document the location and identification of retained specimens if assays need to be repeated.
Ø Other laboratory specimen related trial documents.
Ø Specimen management procedures (collection, performing assay, storage, results).
Ø Subject specimen collection log.
Ø Shipment note, if appropriate.
Ø Temperature recording log, if appropriate (deep frozen samples).
Ø Record of retained laboratory specimens, if any, to document the location and identification of retained specimens if assays need to be repeated.
Ø Other laboratory specimen related trial documents.
Trial supplies/equipment
Ø Material/equipment dispatch note (original) and acknowledgement of receipt (copy).
Ø Return of trial material/equipment certificate (copy).
Ø Trial document dispatch note (original) and acknowledgement of receipt (copy) (CRFs, all trial logs).
Ø Return of trial document certificate (copy).
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