Full list of questions
Investigator-Initiated Trials - Registration of interest
Step 1: Investigator contact information
- Investigator name
- Address
- Tel
- Fax
Step 2: Hospital / Institution /Organization / Study Group information
- Name
- The Hospital / Institution Characterization
- Leader / Board member
- Contact information of the Hospital / Institution / Organization/ Study Group
Step 3: Sponsor information (according to GCP-ICH)
- Name of sponsor
- Address of sponsor
- Telephone
Step 4: Study information
- Date of application for support
- Study title
Step 5: Study protocol synopsis
Note - attachment with supporting scientific information can be uploaded in step 9.
- Introduction
- Hypothesis
- Study design
- Inclusion criteria
- Exclusion criteria
- Primary endpoints
- Secondary endpoints
- Justification for sample size
- Study methods
- Data analysis
- Potential risk vs benefit analysis
- Publication plan
- Key references
Step 6: Study timelines
- Projected Study Start
- Projected Study End
- Initial Data analysis
- Final Data analysis
Step 7: Previous experience as investigator in clinical studies
Note - Investigator CV can be uploaded in step 9.
- Please list a summary of study experience. (including experience as Coordinating Investigator)
Step 8: Budget and drug supply requested from Oncopeptides AB
Note - attachment with detailed budget can be uploaded in step 9.
- Insert below a description of proposed use of funding including if study drug is requested
- Total budget in USD
- Study drug requested (Y/N)
Step 9: Attachments
- Supporting scientific information
- Investigator CV
- Study budget