| SOP 1.pdf |
Introduction |
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Purpose |
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Scope |
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Detailed information |
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-Background |
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-Jurisdiction for the establishment of ERC |
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-Responsibility/Term of Reference (TOR) |
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Flow Chart |
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Glossary |
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References |
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Annexure |
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- Annexure 1 Signature of SOP team |
| SOP 2.pdf |
Preparing Standard Operating Procedure (SOP) |
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Purpose |
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Scope |
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Detailed Instructions |
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-Appoint the SOP Team |
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-Format and layout of SPO |
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- Approve the new/revised SOP |
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- Implement, distribute, and file all SOPs |
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- Request for a revision of an existing SOP |
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Responsibility (Term of Reference TOR) |
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- TOR for Secretariat |
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- TOR for SOP Team Member |
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- TOR for Members Secretary |
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- TOR for Chairman |
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Flow Chart |
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Glossary |
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References |
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Annexure |
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- Annexure 1 List of SOPs |
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- Annexure 2 SOP Format of Landing Page |
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- Annexure 3 SOP Distribution List |
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- Annexure 4 SOP History of List |
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- Annexure 5 SOP Revision Request form |
| SOP 3.pdf |
Structure and Composition of ERC |
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Purpose |
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Scope |
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Detailed Instructions |
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- Ethical Basis |
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- Composition of the ERC, BBS |
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- Dissolving of the ERC, BBS |
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Responsibility (Term of Reference TOR) |
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Flow Chart |
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- Activities and Responsibility |
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- Organogram |
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Glossary |
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References |
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Annexure |
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- Annexure 1 Executive Board (EB) since 2015 |
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- Annexure 1 Ethics Review Committee (ERC) 2020-2025 |
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- Annexure 1 Ethics Review Committee (ERC) 2014-2020 |
| SOP 4.pdf |
Function of ERC |
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Purpose |
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Scope |
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Detailed Instructions |
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- Constitution |
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- Membership Requirements Policy |
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- Who can become an IRB member? |
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- Required Training to be Member of ERC |
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- Resignation, Disqualification, Replacement of Members |
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- Scope of Authority of ERC |
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Responsibility (Term of Reference TOR) |
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- TOR of Executive Board (EB) |
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- TOR of ERC |
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- TOR of the Chairman of ERC |
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- TOR of the Member Secretary of ERC |
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- TOR of the Members of ERC |
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- TOR of Lay Person of ERC |
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- TOR of Secretariate Staff |
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-TOR of Cleaner |
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- TOR of Security Guard |
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Flow Chart |
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Glossary |
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References |
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Annexure |
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- Annexure 1 Member Appointment |
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- Annexure 2 Curriculum Vitae for ERC Member |
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- Annexure 2 Conflict of Interest Agreement Form for ERC Members |
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- Annexure 4 Confidentiality Agreement Form for ERC Member |
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- Annexure 5 Staff Recruitment form |
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- Annexure 6 Conflict of Interest Agreement Form for Staff (English) |
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- Annexure 7 Confidentiality Agreement Form for ERC Staff (English) |
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- Annexure 8 Conflict of Interest Agreement Form for Staff (Bangla) |
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- Annexure 9 Confidentiality Agreement Form for Staff (Bangla) |
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- Annexure 10 Checklist for Office Staff |
| SOP 5.pdf |
Guidelines for Protocol Submission |
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Purpose |
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Scope |
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Detailed Instructions |
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- Check List for Protocol Submission |
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- Note to Ethical Clearance |
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- Protocol Received |
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- Protocol Resubmission |
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- Protocol Amendment |
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Responsibility (Term of Reference TOR) |
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- TOR of Principal Investigator |
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- TOR of Secretariate |
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- Store the received packages |
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Flow Chart |
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Glossary |
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References |
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Annexure |
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- Annexure 1 Project Proforma |
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- Annexure 2 COI for PI |
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- Annexure 3 MOU Between Institute & ERC, BBS |
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- Annexure 4 Checklist for Receive Package |
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- Annexure 5 Document Receipt Form |
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- Annexure 6 Acknowledgement Letter to PI |
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- Annexure 7 Application for Case study/Case series |
| SOP 6.pdf |
Protocol Review |
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Purpose |
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Scope |
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Detailed Instructions |
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- General Review Process |
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- Category of the Review process |
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- - -Exemption of Review Process |
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- - - Expedited Review |
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- - -Full Board Review: |
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- Selection of Independent Consultants |
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- Basic Documents (submit to Primary Reviewer) |
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- Elements shall Reviewed by External /Primary Reviewer |
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- Storage of the document |
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- Process of Review of Protocol Checklist for Reviewer |
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Responsibility (Term of Reference TOR) |
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-TOR of Independent Consultants |
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Flow Chart (Protocol Review) |
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Glossary |
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References |
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Annexure |
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- Annexure 1 Submission Review Checklist |
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- Annexure 2 Request form for Primary Reviewer |
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- Annexure 3 Confidentiality and Conflict of Interest Agreement Form for Primary Reviewer |
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- Annexure 5 Protocol Assessment Form for Primary Reviewer |
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- Annexure 6 Acknowledgment Letter to Primary Reviewer |
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- Annexure 7 Independent Reviewer’s Review Form |
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- Annexure 8 Checklist for Exemption Review |
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- Annexure 9 Expedite review form |
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- Annexure 10 Resubmitted Study Protocol Review Form |
| SOP 7.pdf |
Response to stakeholder's Request/Complaint |
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Purpose |
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Scope |
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Responsibility |
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Detailed Information |
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-Who are the stakeholders |
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- The procedure of processing request/complain |
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Flow Chart |
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Glossary |
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References |
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Annexure |
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- Annexure 1 Request/ complaint form |
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- Annexure 2 Inequity form |
| SOP 8.pdf |
Meeting and Decision |
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Purpose |
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Scope |
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Detailed Instructions |
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- Before ERC meeting |
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- During Conduct meeting |
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- Decision-making |
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- Communicating a decision |
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- Follow-up |
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- Emergency Meeting |
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- Online meetings |
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- Storage of the documents |
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Responsibility (Term of Reference TOR) |
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Flow Chart |
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Glossary |
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References |
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Annexure |
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- Annexure 1 Agenda of the ERC Meeting |
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- Annexure 2 Meeting Minutes of the ERC |
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- Annexure 3 Informed Consent Assessment Form by layperson (English |
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-Annexure 4 Informed Consent Assessment Form by layperson (Bangla) |
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- Annexure 5 Confidentiality Agreement Form for Guest /Authority |
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- Annexure 6 Certificate for Ethical Clearance |
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- Annexure 7 Certificate for Exemption |
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- Annexure 8 Certificate for Exemption of Case Reports |
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- Annexure 9 Certificate for Expedite Review |
| SOP 9.pdf |
Post Approval Monitoring |
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Purpose |
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Scope |
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Detailed Instruction |
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- Review of Resubmitted Protocols |
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- Review of Amendment Protocol |
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- Continuing Review System of Protocol |
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- Review of Protocol Noncompliance/ SEA |
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- Site visit |
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--- Selection of study sites |
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--- Before the visit |
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--- During the visit |
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--- After the visit |
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--- Review of Final Report |
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Responsibility/Term of Reference |
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- TOR of The Chairperson ERC |
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- TOR of Site Visit Team |
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Flow Chart |
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Glossary |
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References |
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Annexure |
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- Annexure 1 Study Protocol Amendment Submission |
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- Annexure 2 Study Protocol Noncompliance (Deviation or Violation) Report |
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- Annexure 3 Suspected, Unexpected, Serious Adverse Event/Reaction/s Report |
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- Annexure 4 SAE AND SUSAR Reports Summary |
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- Annexure 5 Notice of Site Visit |
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- Annexure 6 Site Visit Report Form |
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- Annexure 7 Continuing Review Application Form |
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- Annexure 8 Progress Report Form |
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- Annexure 9 Continue Review Reviewer’s Report |
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-Annexure 10 Continuing Review Report /Progress Report Approval Letter |
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- Final Report Form |
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-Reminders for Submission of Progress /Continue/ Final Report |
| SOP 10.pdf |
Documentation and Archiving |
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Purpose |
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Scope |
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Detailed Instruction |
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- After receiving the notification of termination / final report |
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- Retrieving Documents |
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Responsibility/Term of Reference |
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Flow Chart |
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Glossary |
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References |
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Annexure |
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- Annexure 1 Document History of SOP |
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- Annexure 2 Log of SOP Distribution to Recipients |
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- Annexure 3 Protocol Database |
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- Annexure 4 Memberships database |
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- Annexure 5 Training/Course/ Seminar/ Conference database |
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- Annexure 6 Training Record |
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- Annexure 7 Annual Progress Report Form |
| SOP 11.pdf |
Retention and Disposal Procedure |
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Purpose |
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Scope |
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Detailed Instruction |
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- Legal instruction |
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- Retained Documents forever |
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- Retained Documents for 3 years |
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- Procedure of destroy |
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Responsibility/Term of Reference |
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Flow Chart |
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Glossary |
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References |
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Annexure |
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- Annexure 1 Records Destruction Management form |
| SOP12.pdf |
External / Internal Audit |
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Purpose |
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Scope |
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Responsibility |
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Detailed Information |
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- For External audit |
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- For online audit |
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- For Internal Audit |
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Flow Chart |
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Glossary |
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References |
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Annexure |
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- Annexure 1 Auditing Checklist |