Templates for Drug Trials
- Agreement for Support from External/Commercial Source - Template
- Agreement for Transfer of Clinical Trial Tasks in Decentralised Trials - Template
- Agreement Multicentre Trial - Template
- Archiving log - Template
- Avtale med forskningsstøtte - Template
- Checklist Completion of Clinical Trial - Centre - Template
- Checklist Completion of Clinical Trial - Sponsor - Template
- Checklist Conduct of Clinical Trial - Centre - Template
- Checklist Conduct of Clinical Trial - Sponsor - Template
- Checklist Initiation of Clinical Trial - Sponsor - Template
- Clinical Trial Protocol Site Signature Form - Template
- Close-out Monitoring Report - Template
- Co-monitoring Visit Report - Template
- CTIS Compliance Norwegian Requirements on Data Protection - Template
- Contact Information Study Team - Template
- CTIS Cover letter initial application - Template
- CTIS Cover letter Substantial Modification - template
- CTIS Declaration of Interest - Template
- CTIS Modification description - Template
- CTIS Recruitment and Informed consent procedure - Template
- CTIS RFI Response List of Changes to the Application - template
- CTIS Site Suitability - Template
- CTIS CV for Investigators - Template
- CV for Non-investigators - Template
- Data Management Personnel Log - Template
- Data Management Plan - Template
- Data Management Report - Template
- Data Monitoring Committee Charter - Template
- Data Processing Agreement for Monitoring Services - Template
- Data Processing agreement SUSAR reporting - Template
- Data Verification Plan - Template
- Database Lock Form - Template
- Database Relock Form - Template
- Database Unlock Form - Template
- DEA Approval Form - Template
- DEA Change Log - Template
- Delegation Log - Template
- Feasibility Questionnaire - Template
- CTIS Financial and Other Arrangements - Template
- Green Light for Trial Site - Template
- Identification & Enrollment Log - Template
- IMP Accountability Form Common Stock Unnumbered - Template
- IMP Accountability Form Different Manufacturers - Template
- IMP Accountability Form with Kit or ID-Number - Template
- IMP Destruction - Template
- IMP Handling Checklist - Template
- IMP Reconciliation - Template
- IMP Requisition Form - Template
- IMP Temperature Log - Template
- Individual Case Report Form Eudravigilance - Template
- Informed Consent Form Version Tracking Log - Template
- Investigator's Brochure (IB) - Template
- Investigator's Brochure Checklist - Template
- Investigator’s Site File (ISF) Table of Content - Template
- ISF Index Divider - Template
- Labels for Archiving - Template
- Laboratory Sample Storage Log - Template
- Location of Document if not in ISF - Template
- Meeting Participants List - Template
- Monitoring Plan - Template
- Monitoring Report - Template
- Monitoring Report Biobank - Template
- Pharmacy File Table of Contents - Template
- Power of Attorney - Template
- Prescreening Log - Template
- Principal Investigator (PI) Site Risk Evaluation Checklist Prior to Study Initiation - Template
- Privacy Notice for Clinical Trial Staff - Template
- Protocol - Template
- Protocol Content Checklist - Template
- Protocol Deviation Handling Plan - Template
- Protocol Deviation Log Multicenter Study - Template
- Protocol Deviation Log Single Center Study - Template
- Protocol Deviation Notification and Tracking Form - Template
- Protocol Synopsis - Template
- Protocol Version Tracking Log - Template
- Query List - Template
- Reference Safety Information review Log – Template
- Risk Assessment - Template
- Screening Log - Template
- Signature Log - Template
- Simplified Development Safety Update Report - Template
- Source Data List - Template
- Start-up Meeting Agenda - Template
- Start-up Meeting Checklist - Template
- Statistical Analysis Plan - Template
- Tilleggsavtale med forskningsstøtte - Template
- TMF Index Divider Multicenter Trial - Template
- TMF/ISF Index Divider Single Center Trial - Template
- TMF/ISF Table of Content Single Center Trial - Template
- Training Log - Template
- Trial Handover Procedure and Checklist - Template
- Trial Initiation Report - Template
- Trial Master File (TMF) Table of Content Muliticenter Trial - Template
- User Acceptance Testing (UAT) - Template
- Vurdering av monitoreringsbehov kliniske studier - Templat
- CTIS Compliance with applicable rules for biological samples - Template
- CTIS Statement on compliance Regulation (EU) 2016/679 - Template
Protocol - Template
Sist oppdatert: 09.07.2025
Mer informasjon
Utgiver: NorCRIN
Versjon: 2.3
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Changes from previous version: Appendix 10.1.8 is revised according to ICH-GCP R3 with regards to data governance and oversight of data acquisition tools.
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