All questions

Investigator-Initiated Trials - Registration of interest

Step 1: Investigator contact information

  • Investigator name
  • Address
  • E-mail
  • 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
  • E-mail
  • Telephone

Step 4: Study information

  • Date of application for support
  • Study title

Step 5: Study protocol synopsis

  • 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

  • Please list a summary of study experience. (including experience as Coordinating Investigator)

Step 8: Budget and drug supply requested from Oncopeptides AB

  • Insert below a description of proposed use of funding including if study drug is requested
  • Total budget in USD
  • Study drug requested (Y/N)