To describe the objective(s), design, methodology, statistical considerations, and organization of a trial. Usually also gives the background and rationale for the trial, but these could also be provided in other protocol referenced documents.
To document investigator and sponsor agreement to the protocol.
A summary of the pertinent points of the protocol. A local language version may be translated from core (English) or produced in the country if required by local Regulatory Authorities or IRB/IEC
To document any decision or to clarify any information relating to this zone. Only Filenotes relevant for the study conduct at the site must be filed”
Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes. Only key communications relevant for the study conduct at the site must be filed”
Zone-specific documents developed for the purpose of tracking activities during the course of the trial. Only Tracking information relevant for the study conduct at the site must be filed”
Documents describing the trial or changes/updates to the trial submitted to an IRB/IEC for approval, including recruitment and education materials and responses to questions from IRB/IEC to support a submission. Intended to include a list of attachments or table of contents of submission dossier/package. The submitted study documents such as Investigator Brochure, Informed Consent Forms, etc. may or may not be filed as a complete Dossier within this Subsection.
Documentation received from IRB/IEC in response to submission indicating approval/acknowledgement of trial and any specifications or modifications. Records referenced by the approval (such as a Protocol that has been approved) should be filed elsewhere in the ISF, as appropriate, as long as there is identification of the approved record within the IRB/IEC letter or acknowledgement.
Documentation that the IRB-IEC consists of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. These details vary by local regulations.
Documentation verifying non-voting members of the IRB-IEC if the investigator or sub-investigator is on the IRB-IEC.
Documentation that the IRB-IEC is performing its function according to written operating procedures and is in compliance with GCP and applicable regulatory requirements.
To assure the IRB/IEC are promptly notified of all findings (new, important information on serious adverse events and or safety concerns) that could adversely affect the safety of subjects, impact the conduct of the trial or alter the IRB/IEC’s approval/favorable opinion to continue the trial. Notifications/Communication may include but are not limited to - periodic safety line listings, USADEs, SUSARs, CIOMS, MedWatch, Analysis of Similar Events, cover letters and/or IRB/IEC-specific reporting forms.
Document detailing the termination of a study – whether upon completion or premature termination.
Regular reports concerning trial conduct, other than safety reports, issued to the IRB/IEC by the sponsor/3rd Party and/or investigator.
A set of documents describing the trial or changes/updates to the trial submitted to a committee other than the IRB/IEC for approval. To include: Submissions and Correspondence The submitted study documents such as Protocol, Investigator Brochure, Informed Consent Forms, etc. are filed elsewhere in the ISF, as appropriate, as long as there is identification of the submitted record within the submission correspondence.
Approval documentation received from a committee other than the IRB/IEC in response to submission indicating approval/acknowledgement of trial specifications or modifications. To include: Submissions and Correspondence. Approved records referenced by the approval (such as a Protocol, Investigator Brochure, Informed Consent Forms, etc) are filed elsewhere in the ISF, as appropriate, as long as there is identification of the approved record within the other committee approval
To document any decision or to clarify any information relating to this zone. Only Filenotes relevant for the study conduct at the site must be filed.
Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes. Only key communication relevant for the study conduct at the site must be filed.
Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting which documents any agreements or significant discussions. Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material. Only Meeting materials relevant for the study conduct at the site must be filed
Zone-specific documents developed for the purpose of tracking activities during the course of the trial. Only Tracking Information relevant for the study conduct at the site must be filed”
5.3. IP Shipment Documentation 5.4. IP Accountability Documentation 5.5. IP Transfer Documentation 5.6. IP Re-labelling Documentation 5.7. IP Recall Documentation 5.8. IP Quality Complaint Form 5.9. IP Return Documentation 5.10. Certificate of Destruction 5.11 IP Retest and Expiry Documentation 5.12. QP (Qualified Person) Certification 5.13 IP Regulatory Release Documentation 5.14. Certificate of Analysis 5.15. IP Treatment Allocation Documentation 5.16. IP Unblinding Plan 5.17. IP Treatment Decoding Documentation 5.18. IP Storage Condition Documentation 5.19. IP Storage Condition Excursion Documentation 5.20. IRT User Manual 5.21. IRT User Account Management 5.22. Filenote 5.23. Relevant Communications 5.24. Tracking Information # 6. Non-IP Supplies 6.1. Non-IP Shipment Documentation 6.2. Non-IP Return Documentation 6.3. Non-IP Storage Condition Log 6.4. Non-IP Storage Condition Excursion Documentation 6.5. Maintenance Logs (Device) 6.6. Filenote 6.7. Relevant communication 6.8. Tracking information # 7. Laboratory 7.1. Certification or Accreditation 7.2. Laboratory Validation Documentation 7.3. Laboratory Results Documentation 7.4. Normal Ranges 7.5. Manual 7.6. Supply Import Documentation 7.7. Head of Facility Curriculum Vitae 7.8. Standartization Methods 7.9. Specimen Label 7.10. Shipment Records 7.11. Sample Storage Condition Log 7.12. Sample Import or Export Documentation 7.13. Record of Retained Samples 7.14. Filenote 7.15. Relevant Communication 7.16. Tracking information 7.17. Meeting Material # 8. Safety 8.1. Investigator’s Brochure 8.2. Acceptance of Investigator Brochure 8.3. Marketed Product Material 8.4. Notification to Investigators of Safety Information 8.5. SAE Report 8.6. Pregnancy Report 8.7. Overdose 8.8. Special Events of Interest 8.9. Expedited Safety Report 8.10. Filenote 8.11. Relevant Communications 8.12. Tracking Information # 9. Subject Documentation 9.1. Informed Consent Form 9.2. Subject Information Sheet 9.3. Other Written Information Given to Subjects 9.4. Subject Participation Card 9.5. Subject Questionnaire 9.6. Subject Diary 9.7. Advertisements for Subject Recruitment 9.8. Informed Consent Form - signed by patient (may be included into the medical records/card) 9.9. Filenote 9.10. Relevant Communications 9.11. Tracking Information # 10. Data Management 10.1.Sample Case report Form 10.2. CRF/ePRO Completion Requirements 10.3. Documentation of Corrections to Entered Data 10.4. Investigator Receipt of Final Data 10.5. Filenote 10.6. Relevant Communications # 11. Site Management 11.1. Confidentiality Agreement 11.2. Data Privacy Agreement 11.3. Form FDA1572 11.4. Principal Investigator Curriculum Vitae 11.5. Sub-Investigator Curriculum Vitae 11.6. Other Curriculum Vitae 11.7. Site Staff Qualification Supporting Information 11.8. Investigator Regulatory Agreement 11. 9. Investigator’s Agreement (Device) 11.10. Site Signature Sheet 11.11. Site Contact Details 11.12. Meeting Material 11.13. Site Training Material 11.14. Site Evidence of Training 11.15. Site Visit Log 11.16. Trial Initiation Monitoring Report 11.17. Relevant communications 11.18. Monitoring Visit Confirmation Letters to site 11.19. Monitoring visit follow-up letters 11.20. Site Ready to Enroll Confirmation 11.21. Subject Log 11.22. Subject Eligibility Verification Forms and Worksheets 11.23. Source Data Verification 11.24. Source data 11.25. Coordinating Investigator Documentation 11.26. Filenote 11.27. Tracking Information # 12. Study Management 12.1. Recruitment Plan 12.2. Communication Plan 12.3. Debarment statement 12.4.Investigator Newsletter 12.5. Investigators Meeting Material 12.6. Clinical Study Report Synopsis 12.7 Audit Certificate 12.8. Trial Team Contact details 12.9. Filenote 12.10. Relevant Communication 12.11. Tracking information