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SOP Chapter 1
- DLSMHSI-IEC FORM 1A1-V2-2019- Letter of Appointments of DLSMHSI-IEC Members
- DLSMHSI-IEC FORM 1A2-V2-2019- Letter of Appointments of DLSHSI-IEC Chair
- DLSMHSI-IEC FORM 1A3-V2-2019- Letter of Appointments of DLSHSI-IEC Co-Chair
- DLSMHSI-IEC FORM 1A4-V2-2019- Letter of Appointments of DLSHSI-IEC Member – Lay
- DLSMHSI-IEC FORM 1A5-V2-2019- Letter of Appointments of DLSHSI-IEC Member – Secretary
- DLSMHSI-IEC FORM 1A6-V2-2019- Letter of Appointments of DLSHSI-IEC Independent Consultant
- DLSMHSI-IEC FORM 1A7-V1-2019- Letter of Appointments of SAE Subcommittee
- DLSMHSI-IEC FORM 1B-V1-2012- Confidentiality and COI Agreement (for Members Independent Consultants)
- DLSMHSI-IEC FORM 1B-V1-2012- Confidentiality and COI Agreement (for Members Independent Consultants)_SAE SUBCOMMITTEE
- DLSMHSI-IEC FORM 1C-V1-2012- Curriculum Vitae (for IEC Members)
- DLSMHSI-IEC FORM 1D-V1-2012- Training Record of DLSHSI-IEC Member & Staff
- DLSMHSI-IEC FORM 1E-V2-2019- Recommendation Letter
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SOP Chapter 2
- DLSMHSI-IEC FORM 2A-V2-2019-Protocol Submission Checklist
- DLSMHSI-IEC FORM 2B-V1-2012- Protocol Review Application
- DLSMHSI-IEC FORM 2C-V1-2012- Curriculum Vitae (for Investigators)
- DLSMHSI-IEC FORM 2D-V2-2019- ICF Assessment Form
- DLSMHSI-IEC FORM 2D-V2-2019- Protocol Assessment Form
- DLSMHSI-IEC FORM 2E-V1-2012- Review of Resubmitted Protocol
- DLSMHSI-IEC FORM 2E-V2-2020- Review of Resubmitted Protocol
- DLSMHSI-IEC FORM 2F-V1-2012- Acknowledgement Letter (for Protocol Submission)
- DLSMHSI-IEC FORM 2G-V1-2012- Protocol Tracking Sheet
- DLSMHSI-IEC FORM 2H-V2-2019-Notification Letter (for Modification Prior to Approval)
- DLSMHSI-IEC FORM 2I-V2-2019- Approval Letter (for Reviewed Protocols)
- SOP Chapter 3
- DLSMHSI-IEC FORM 3A-V3-2019- SAE Report
- DLSMHSI-IEC FORM 3B-V2-2015- Protocol Amendment Application
- DLSMHSI-IEC FORM 3C-V2-2015- Continuing Review Application
- DLSMHSI-IEC FORM 3D-V2-2015- Final Report
- DLSMHSI-IEC FORM 3E-V1-2012- Non-Compliance (Deviation,Violation) Report
- DLSMHSI-IEC FORM 3F-V1-2012- Early Study Termination Report
- DLSMHSI-IEC FORM 3G-V1-2012- Site Visit Report
- DLSMHSI-IEC FORM 3H-V1-2012- AE Summary Report
- DLSMHSI-IEC FORM 3I-V1-2012- Queries or Complaints Report
- DLSMHSI-IEC FORM 3J-V1-2012-SAE SUBCOMMITTEE Recommendation Form
- DLSMHSI-IEC FORM 3K-V2-2019-Close-Out Form
- SOP Chapter 4
- DLSMHSI-IEC FORM 4A-V1-2012- Format of Notice of Meeting
- DLSMHSI-IEC FORM 4B-V2-2019- Format of Minutes of Regular Meeting
- DLSMHSI-IEC FORM 4C-V1-2012- Confidentiality & COI Agreement (for Guests, Observers)
- DLSMHSI-IEC FORM 4D-V1-2012-Notification Letter (Others)
- DLSMHSI-IEC FORM 4E-V1-2012-Approval Letter (for Protocol Amendment)
- DLSMHSI-IEC FORM 4F-V1-2012-Approval Letter (for Additional Materials)
- DLSMHSI-IEC FORM 4G-V1-2012-Notification Letter_Others (Uphold)
- DLSMHSI-IEC Form 4G-V2-2019 – Notification Letter (Reviewed Reports)
- DLSMHSI-IEC FORM 4H-V1-2012-Notification Letter (for Modification Prior to Approval) Amendments
- DLSMHSI-IEC FORM 4I-V1-2012- Notification letter (for Protocol Not Requiring Review)
- DLSMHSI-IEC FORM 4J-V1-2012 – Notification Letter_(Request for Information_Recommend Further Action_Others)
- DLSMHSI-IEC FORM 4J-V1-2012- Approval Letter (for Final Report, Early Study Termination Application)
- DLSMHSI-IEC FORM 4K-V1-2012- Approval Letter (for Final Report, Early Study Termination Application)
- DLSMHSI-IEC FORM 4K-V1-2012- Reminder Letter (for Post-Approval Requirement)
- DLSMHSI-IEC FORM 4L-V1-2012- Notification Letter (for Site Visit)
- DLSMHSI-IEC FORM 4L-V1-2012- Reminder Letter (for Post-Approval Requirement)
- DLSMHSI-IEC FORM 4M-V1-2012- Acknowledgement of Receipt Letter
- DLSMHSI-IEC FORM 4M-V1-2012- Notification Letter (for Site Visit)
- DLSMHSI-IEC FORM 4N-V1-2012- Acknowledgement of Receipt Letter
- DLSMHSI-IEC FORM 4N-V1-2012- Notice of Corrective Action
- DLSMHSI-IEC FORM 4O-V1-2012- Notice of Corrective Action
- DLSMHSI-IEC FORM 4O-V1-2012- Notification Letter (Letter of Disapproval)
- DLSMHSI-IEC FORM 4P-V1-2012- Request Letter (for Content Expert)
- DLSMHSI-IEC FORM 4P-V1-2012- Notification Letter (Letter of Disapproval)
- DLSMHSI-IEC FORM 4Q-V1-2012- Request Letter (for Content Expert)
- DLSMHSI-IEC FORM 4Q-V1-2012- Notification of Delay (for Protocols Referred to Content Expert)
- DLSMHSI-IEC FORM 4R-V1-2012- Approval Letter(for Approval of Continuing Review Application)
- DLSMHSI-IEC FORM 4R-V1-2012- Notification of Delay (for Protocols Referred to Content Expert)
- DLSMHSI-IEC FORM 4S-V1-2012- Approval Letter(for Approval of Continuing Review Application)
- DLSMHSI-IEC FORM 4S-V1-2012- Invitation for Clarificatory Interview
- DLSMHSI-IEC FORM 4T-V1-2012- Acknowledgement Letter (for Protocol Withdrawal)
- DLSMHSI-IEC FORM 4T-V1-2012- Invitation for Clarificatory Interview
- DLSMHSI-IEC FORM 4U-V1-2012- Acknowledgement Letter (for Protocol Withdrawal)
- SOP Chapter 5
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