Institutional Review Board (IRB)

DOWNLOADABLE FORMS

Access essential IRB forms and standard operating procedures for ethical research oversight. Download the necessary documents to ensure compliance with regulatory and ethical guidelines.

STANDARD OPERATING PROCEDURE
Chapter 1 - IRB Structure and Composition
1.1 - Ethical Framework and Constitution of the IRB
1.2 - Selection of Independent Consultants
1.3 - Training Personnel and Ethics Committee Members
1.4 - Confidentiality or Conflict of Interest Agreement
1.5 - Incentives for IRB Members and Consultants
Chapter 2 - Types of Review
2.1 - Expedited Review
2.2 - Full Board Review
Chapter 3 - Initial Review
3.1 - Management of Protocols Submissions
3.2 - Use of Study Assessment Form
3.3 - Review of Medical Device Study
Chapter 4 - Continuing Review
4.1 - REVIEW OF FINAL REPORT
4.2 - Study Protocol Amendment
4.3 - Review of Serious Adverse Event (SAE) Reports
4.4 - Management of Protocol Deviation and Violation
4.5 - Management of Study Termination
4.6 - SOP on Protocol Continuing Review
Chapter 5 - Meetings
5.1 - Preparation and Conduct of Meeting
5.2 - Emergency Meetings and other matters
Chapter 6 - Documentation and Management of Files and Archiving
6.1 - Preparation of the Minutes of the IRB Meeting
6.2 - Communicating IRB Decisions Incoming Outgoing Communications
6.3 - Management of the Active Files
6.4 - Archiving and Retrieval of Documents
6.5 - Maintenance of Confidentiality of Study Files and IRB Documents
Chapter 7 - Site Monitoring Visits
7.1 -Site Monitoring Visits
Chapter 8 - Response to Research Participants Request
8.1 - Response to Research Participants Request
Chapter 9 - Writing and Revising SOPs
9.1 - Writing, Reviewing, Distributing and Amending SOP for IRB
10 - Glossary

DOWNLOABLE FORMS
APPLICATION FORM (for RESIDENTS STUDY) 1 of 4
APPLICATION FORM (for RESIDENTS STUDY) 2 of 4
APPLICATION FORM (for RESIDENTS STUDY) 3 of 4
APPLICATION FORM (for RESIDENTS STUDY) 4 of 4
APPLICATION FORM (for SPONSOR INITIATED STUDY) 1 of 4
APPLICATION FORM (for SPONSOR INITIATED STUDY) 2 of 4
APPLICATION FORM (for SPONSOR INITIATED STUDY) 3 of 4
APPLICATION FORM (for SPONSOR INITIATED STUDY) 4 of 4
ICF STANDARD TEMPLATE FORM
INVESTIGATORS BROCHURE STANDARD TEMPLATE FORM
PROTOCOL AMENDMENT STANDARD TEMPLATE FORM
PROTOCOL AMENDMENT SUBMISSION FORM
CONTINUING REVIEW APPLICATION FORM
END OF STUDY REPORT FORM
PROTOCOL DEVIATION-VIOLATION RECORD FORM
SERIOUS ADVERSE EVENT REPORT FORM
UNEXPECTED ADVERSE EVENT REPORT FORM