Investigator Support


CRAC Submission Process


Guidelines for Formulating, Writing and Submitting Clinical Trial Proposals

Clinical Trials Flow Chart

This is a checklist to help you organize and consolidate your study proposal. The goal is to have you consider all aspects of your study before you write the proposal so that you minimize questions raised in the review process.

You are strongly encouraged to contact the CTO (cvm-clinicaltrials [at] osu [dot] edu) prior to filling out this form if you have not completed a form in the past. You should also consider having the CTO evaluate your form prior to submission to ensure that all required elements are present. Once you have completed the CRAC form, please email to Nicole Stingle at stingle [dot] 5 [at] osu [dot] edu.

If you need help with this process or have questions, please contact the Clinical Trials Coordinator (Nicole Stingle or Tamra Mathie at cvm-clinicaltrials [at] osu [dot] edu). In addition to the CRAC form, most clinical trials performed at the OSU VMC will require Animal Use Protocol approval by the IACUC prior to enrolling patients.

All relevant Forms

Informed Consent Examples

Animal Use Protocol Approval

Any study that will utilize client-owned animals is considered a clinical trial, and all clinical trials conducted at the OSU Veterinary Medical Center currently require approval from the IACUC (Institutional Animal Care and Use Committee) unless the Clinical Research Advisory Committee has determined that such approval is not required, in which IACUC would provide an exemption letter . It is suggested that you contact the CTO (cvm-clinicaltrials [at] osu [dot] edu) to determine whether you may be exempt from this requirement. In general, any study that involves procedures/treatments that would not be routinely part of standard of care for a particular disease (i.e., collection of additional blood samples, additional imaging, etc.) will necessitate obtaining IACUC approval. For clinical trials at the VMC, an Animal Use Protocol is used. IACUC requires that all individuals listed on an Animal Use Protocol complete the online Animal Training courses, along with their Experience and Training Narrative.

  • Submit a Animal Use Protocol form to the Office of Responsible Research Practices.
  • List the number of your approved Animal Use Protocol or exemption letter on your title page and provide the Clinical Trials Office with a copy of the approval or exemption letter.

Research Administration Toolbox

Forms

IACUC Training

All personnel listed on an IACUC will need to complete the online training courses (except Facility Training), along with their Experience and Training Narrative.

Good Clinical Practice (GCP)

Good Clinical Practice is a set of guidelines that must be followed when conducting clinical trials to ensure that the rights and well-being of the trial participants are protected and that the data generated in the trial is valid.

12 Golden Rules

  1. Investigators must have appropriate qualifications and time for study
  2. Know and follow the study protocol
  3. Provide sufficient qualified and capable study personnel
  4. Carefully select suitable patients
  5. Obtain informed consent and protect animals’ welfare
  6. Ensure study facilities and equipment are adequate
  7. Record all data carefully
  8. Meticulously Document product accountability
  9. Collect and record adverse events and changes in animal health
  10. Ensure the appropriate handling of study laboratory specimens
  11. Maximize data quality
  12. Maintain good trial files and perform study conclusion tasks

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