Research Project Document Submission Check List Format
- Ethics Committee
- Introduction
- Notification
- Instructions for Research Project Submission Document Application
- Sample Project
- Amendments to Protocol / Communications Protocol
- Principal Investigator Change Protocol
- Application Letter for Release of Finances
- Submission Letter for Deposits towards Project
- Submission Letter for Serious Adverse Effects for Research Project
- Research Project & Amendments Processing Fees
- Research Project Document Submission Check List Format
- Acknowledgement Form Format
- Title Page Format
- Joint Undertaking by Principal Investigator and Sponsor Format
- Project Index page Format
- Covering Letter Format
- Project Summary Format
- Research Protocol Application Format
- Project Completion Letter Format
A. Research Project Document Submission Check List Format
Research Project Document Submission Check List
| Sr.No | Page Heading | Pg. No. | PIChk | SRSChk | ||
| i. | Communications and Amendments Dispatch Noting Page ( 1 blank page with heading ) * | |||||
| ii | IEC Agenda & Minutes of Meeting Noting Page ( 2 blank Pages with heading ) * | |||||
| iii | Xerox copy of Research Project Application Fee Receipt ( as issued by SRS Office )* | |||||
| iv | Acknowledgement Form in given SRS format * | |||||
| v | Title Page in given SRS format * | |||||
| vi | Brief Curriculum vitae of Principal Investigator ( max 2 pages) * | |||||
| vii | Covering Letter in given SRS format * | |||||
| vii | Joint Undertaking by Sponsor ( if applicable ) & Principal Investigator in given SRS format * | |||||
| ix | Project Index Page in given SRS format * | |||||
| I | Project Format | |||||
| a. | Project Summary in given SRS format * | |||||
| b. | Research Project Application Form in given SRS format * | |||||
| c. | References * | |||||
| d. | Project specific Patient Information Sheet ( 3 languages ) * | |||||
| e. | Project Specific Informed Consent Form ( 3 Languages ) * | |||||
| f. | Project Specific Case Record Form / Questionairre / Patient Diary * | |||||
| II | Additional Documents ( as applicable ) see Index Page format | |||||
| a. | Insurance Cover * ( compulsory for sponsored Projects ) | |||||
| Project Closure Letter in given format * | ||||||
| x. | Entire Document submission ( except Documents submitted under ” Additional Documents”) on a CD *– Word Format 2003 with Abbreviated Project Title, Sponsor name & PI written on the CD by a permanent marker pen. | |||||
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