Forms & Requisitions
Versiti Clinical Trials requires completed requisition forms with each submitted patient sample performed at Versiti Diagnostic Laboratories. Please note: If RNA or DNA samples are being sent, isolation of nucleic acids for clinical testing must occur in a CLIA-certified lab or a lab meeting equivalent as determined by CAP and/or the CMS.
In addition to conducting comprehensive patient sample testing, Versiti Clinical Trials supports clinical trials by providing blood products for research. When requesting blood products for research, you must provide one of the following documents:
- IRB Protocol and Approval
- IRB Protocol and Waiver/Exemption
- Letter of Intent and Protocol
- Biologics License Application
Study-specific laboratory manuals are created for each clinical trial and should be used when placing orders for kits and supplies. Kits must be ordered as needed – they are not automatically resupplied. To order collection kits and supplies, please:
- Fax the Supply Request Form found in the Cenetron lab manual to 512-439-5000
- Complete and submit the Supply Order Form online
For your convenience, submission forms are created using Microsoft Word and contain editable text fields that allow you to type directly into the form. You may save the form to your computer for completion at a later time.
Submissions may be sent using SafeSync, our secure online submission system. Salus also accepts submissions through email at salus@salusirb.com, but we recommend utilizing SafeSync because of its ability to manage large files.
Upon initial submission, Salus IRB maintains the investigator files listed below. Form 110.A requests investigator and site information that remains consistent from study to study. Once on file, this form may be used for subsequent submissions. Promptly notify Salus of any changes to the information supplied on Form 110.A.
The following files remain active with Salus IRB, once submitted:
- Form 110.A Investigator and Site Information
- Investigator CV: effective for 2 years from the signature date, or if no signature, receipt date
- Investigator license: effective until the expiration date
- Investigator training
- Site SOPs: if submitted and applicable
- Regulatory audits
- Other investigator or site related attachments, as submitted
Initial submission forms for Single-Site Research/Local Review*:
- Initial Review Protocol (Form 100)
- Supplemental for Drug Research (Form 100.A), submit if applicable
- Supplemental for Device Research (Form 100.B), submit if applicable
- Investigator and Site Information (Form 110.A), submit only if not already on file with Salus or if there are changes
- Protocol Specific Investigator and Site Resources (FORM 110.B)
Initial submission forms for Multi-Site Research in which Salus IRB is the central IRB: for project managers/sponsor representatives*:
- Designation of, or Change in, Project Manager/Sponsor Representative
- Initial Review Protocol (Form 100)
- Supplemental for Drug Research (Form 100.A), submit if applicable
- Supplemental for Device Research (Form 100.B), submit if applicable
For Investigators participating in Multi-Site Research in which Salus IRB is the central IRB*:
- Investigator and Site Information (Form 110.A), submit only if not already on file with Salus or if there are changes
- Protocol Specific Investigator and Site Resources (Form 110.B)
*Additional submission forms for initial review, as applicable:
- Supplemental for Expedited Review of Minimal Risk Research (Form 100.C)
- Supplemental for Exempt Research (Form 100.D)
- Supplemental for International Research (Form 100.E)
- IRB Authorization Agreement
- Request for Full Waiver or Alteration of Informed Consent or Waiver of Parental Permission
- Request for Waiver of Documentation of Informed Consent
- Request for Waiver of HIPAA Authorization
Federal regulations require IRBs to conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year as determined by the IRB. Salus IRB requires a study status report at least two weeks prior to the IRB approval expiration date and sends a reminder notice four weeks before your approval expires.
Single Site Research/Local Review (investigator participating in Single-Site Research)
Multi-Site Research (Multi-Site Research in which Salus IRB is the central IRB)
Study Closure
Use these forms to request IRB approval for changes to research during the study approval period: