RFI Questionnaire Template for Clinical Trial Vendor Qualification

What to include in a Request for Information questionnaire for clinical trial service Providers

PDF template preview

As a clinical trial Sponsor, it is essential to ask the right questions of your suppliers to manage your risks and align with global regulations. But how do you know which questions will help you qualify vendors and identify the right partners for your trial? How do you ensure compliance with ever-evolving global regulations?

We use a robust Request for Information (RFI) qualifying questionnaire (also known as the Core RFI) which is completed by every service or technology vendor in Diligent so the details are readily available for clinical trial Sponsors. The RFIs in Diligent use the most effective questions to qualify providers because they are based on the industry standards agreed upon by the 225+ member companies of the WCG Avoca Quality Consortium.

In our free RFI pdf template download, we list 20 wide-ranging question categories that you should use to qualify vendors and benchmark them against best-in-class industry standards. We have also included a sample question for each question category. These categories, and the sample questions, are drawn from the Core RFI in the Diligent Platform.

See what kind of questions go into these RFIs, what topics they cover, and what level of detail they ask in our free RFI Template using the form to the right.

Download our free RFI Template of vendor qualification questions

  • Top 20 question categories 
  • Example questions

The RFI Qualification Questionnaire

At Diligent, we use RFI or Request for Information to mean a Qualification Questionnaire to capture the information needed to qualify clinical trial service and technology vendors against leading industry standards. Our RFIs are unique and built using standards developed by the WCG Avoca Quality Consortium (AQC).

The importance of qualifying vendors to reduce risk

Clinical research is riddled with risks. There are the obvious risks, such as a Serious Adverse Reaction to an investigational product, but also risks buried in the detail. For example, the FDA refused to license a new therapy recently as a tiny piece of functionality was missing in the software used within the trial which meant an error could have crept into the trial data.

As a trial sponsor, you are ultimately responsible for the actions of the service providers in your trial. So it’s essential that you understand the capabilities, resources and processes used by all the service and technology vendors that you might use so that you can understand and manage the risks involved.

What makes an effective RFI qualifying questionnaire?

The most effective RFIs cover a wide range of potential risk areas to ensure a thorough evaluation of each vendor’s capabilities, qualifications and SOPs. It takes time, organization and experience to know what should be evaluated, to what level of detail, and to what specific questions should be asked. Also, you need to ensure relevance to current best practices and global legislation to reduce risk and ensure your clinical trial will be FDA-compliant.

For example, are you analyzing the prospective vendor’s Quality Management System, and if so, are you asking about their document management and control processes? Are you aware of the latest regulations that may apply to your GCP vendor, and if so, the questions that need to be asked to ensure they are compliant?

There is a lot of detail that must go into the RFI to give trial Sponsors the information they need for an appropriate level of insight into each vendor they may work with. That’s why the Core RFI in the Diligent Qualification Platform contains 420 questions to cover all major areas of risk. Even top pharma and biotech companies in the industry don’t always ask the most effective questions to proactively identify all major risks.

Benchmarking against industry standards for clinical research

Every supplier in the Diligent Platform completes our rigorous RFI questionnaires which were developed by the WCG Avoca Quality Consortium and its 200+ member companies of leading pharma, biotech, CROs and clinical service or technology providers. By reviewing vendors’ RFI answers, trial sponsors can benchmark vendors against one another, current regulations and best practices, and the risk profile of their trial.

We know the right questions to ask to properly evaluate if clinical vendors are compliant with all applicable global GCP Regulations. We save our clients from having to figure out what to evaluate to identify and manage risks.

Diligent can help you with Provider qualification, saving you time and effort because:

    1. We have a readily available comprehensive Core RFI questionnaire, plus 28 specific questionnaires that cover different service areas like patient recruitment, biostatistics, clinical monitoring, or Electronic Regulatory Binders (eISF).
    2. We have over 1000+ service and technology providers on the platform. 
    3. We solicit answers from Providers on your behalf, and review these answers for completeness and notify you when available.
    4. We post completed questionnaires on the Diligent Qualification Platform, where you can even compare 2 or 3 providers side by side for each question.

For more details or a free demo of the Diligent Qualification Platform