To submit a new study to Sterling, please log into SilverLink or request access to our secure web portal.
For New Study Design/Protocol Submissions (Sponsor/CRO):
- New study submission application
- Protocol
- Sub-study materials and documentation (if applicable)
- Consent document — Chapter 8 of Sterling IRB’s Handbook includes guidelines for consent form development
- Study-wide recruitment materials and study-related/retention materials (instructions, diaries, etc.)
- Investigator’s drug brochure or package insert (if applicable)
- Manual of operations/instructions for use (for device studies)
For Single-Site or Investigator-Initiated Studies:
- New study submission application
- Protocol
- Consent document(s)
- Recruitment materials and study-related/retention materials (instructions, diaries, etc.)
- Investigator’s drug brochure or package insert (if applicable)
- Manual of operations/instructions for use (if applicable for device studies)
- Submission application for the investigator/site
- Curriculum vitae of the certified principal investigator (unless a current CV has been submitted to Sterling IRB within the last two years)
- Copy of principal investigator’s DEA registration (if applicable)
For New Registry Study Design/Protocol Submissions (Sponsor/CRO):
- New study submission application
- Study protocol
- Consent document(s)
- Study-wide recruitment materials and study-related/retention materials (instructions, diaries, etc.)