Investigator Initiated Study Milestones
IIT Project Assumptions:
- Final Protocol
- First Patient In (FPI)
- Last Patient In (LPI)
- Last Patient Last Visit
- Database Lock
- LPI to database lock
- Analysis
- Investigational Site and Investigators Evaluation and Selection
- Site qualification visit
- Site evaluation report
- Others
- Individual IRB and Regulatory Submission
- Obtain PI's signature page, CV, GCP certificates
- Submission package preparation for HSA submission
- Amendment submission package preparation for HSA submission
- Reply the comments from HSA and obtain approval letters
- Reply the comments from HSA and obtain approval letters
- Submission package preparation for IRB submission
- Amendment submission package preparation for IRB submission
- Reply the comments from IRB and obtain approval letters
- Yearly IB updates (Study Status Report Form)
- Renewal of clinical trial cert
- Others
- Clinical Monitoring Activities (I’m not too sure if this segment is applicable to SingHealth PI, maybe to CTCU)
- Investigator Meeting
- Study Team training
- Investigational drug distribution (if any)
- Site Initiation
- Prepare & maintain trial master file
- Monitoring plan
- Interim monitoring / Source data verification (SDV)/Monitoring Visit report/FU Letter/ travel time
- Review of Monitoring report
- IMP management
- Specimen management and shipment
- SAE reporting
- Protocol Development
- Medical Monitoring (PV or Data Safety Monitoring)
- Medical Monitor cover for XX months plus review of documentation
- Medical Monitor cover for XX months plus review of documentation
- Others
- Data Management
- Case report form (CRF) design & development
- CRF instruction guideline
- CRF and completion guideline amendment
- Annotated CRF preparation
- Database specification review and amendment
- Validation rules development & programming
- Draft database review & testing
- Database live
- Database amendment (if any)
- Validation rules amendment (if any)
- Data entry guideline development and training
- Data Entry
- Query generation & resolution
- Database lock
- Database Maintenance
F. Statistical Analysis
- Protocol development & revision for statistical section
- Randomization
- Statistical analysis plan (if any)
- Statistical analysis
- Statistical analysis report/manuscript
- Others
- Site QC, Close-out & Inspection
- Site QC
- Close out activities and visits
- Others
- Randomisation
- Preparation of studies and code list
- Setting up study
- Loading and preparing test case for assignment
- Monitoring test result
- Documentation of test result
- Preparing and coordinating production detail
- Administration
- Database maintenance
- Troubleshooting and maintenance of studies