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Resources | Investigator-Initiated Studies

Find the resources and information you need to prepare and submit your request to QuidelOrtho for investigator-initiated studies.

What is an investigator-initiated study (IIS)?

An IIS is a research effort in which an independent investigator initiates and conducts a study, and the investigator, often an academic or healthcare institution, is the study sponsor. The investigator assumes all responsibility for complying with applicable regulatory requirements.

QuidelOrtho does not act as the study investigator or sponsor but may provide product or financial support within the following guidelines:

  • QuidelOrtho support for an IIS may be in the form of material or product support or financial funding, as allowed under local laws and regulations. 
  • IIS requests must align with QuidelOrtho’s areas of interest and should benefit the greater body of knowledge in in vitro diagnostics.

Clinical chemistry areas of interest:

  • Studies with a focus on the below clinical areas:
    • Cardiology
    • Infectious Disease
    • Pediatrics
    • Endocrinology

Molecular areas of interest:

  • Studies with a focus on the clinical areas of respiratory and lesion testing, specifically studies that would involve:
    • Under-represented patient populations (e.g., immunocompromised, persons of color, solid organ transplant recipients or people who identify as LGBTQ+)
    • Non-traditional testing environments (e.g., mobile clinics, long-term care facilities)

Transfusion medicine areas of interest:

  • Immunohematology
  • Donor Screening

Point-of-Care areas of interest:

  • Cardiac
  • Infectious Disease
  • Toxicology
  • Pre-eclampsia 

You should discuss your study design and concept with a QuidelOrtho medical science liaison or medical affairs manager to ensure alignment with our areas of interest.  You can also submit your study idea online through the contact us form.

  • Step 1: Submit IIS synopsis/concept or protocol and any relevant details regarding the type of QuidelOrtho support requested.
  • Step 2: QuidelOrtho IIS committee reviews requests for financial, scientific, clinical, legal and regulatory considerations, then renders a decision based on a consensus from the voting members.
  • Step 3: If study request is approved, an IIS agreement between the investigator/institution and QuidelOrtho will be generated.

To generate the IIS agreement, the investigator must provide:

  • The final study protocol
  • Ethical committee or Internal Review Board ("IRB”) approval of the study
  • Informed consent form
  • Principal investigator curriculum vitae

If the IIS request is approved, the study investigator is expected to:

  • Adhere to all Terms and Conditions set forth in the executed Agreement between the Institution, PI and QuidelOrtho.
  • Provide QuidelOrtho with study updates including completion of key milestones and deliverables according to agreed-upon timelines.
  • Communicate in a timely manner regarding material needs if product support is requested. Deliver final study report or manuscript drafts in a timely manner, as agreed upon.