Questions a Sponsor Should Ask a CRO

While I was browsing through my website analytics, I came across the above question that was entered into a search engine which in turn directed somebody to the website. It got me thinking what a great question it was! So, from a records management perspective, what ARE the questions that should be asked? Or put another way, what issues do you need a discussion on when contemplating outsourcing business activities? The list below is not comprehensive but might be helpful and should stimulate some discussion!

  • Do you have a written records retention schedule? Is it signed off by senior management? Is it known about across the organisation? Is it followed?
  • How are records managed whilst they are active? How is the reliability, authenticity, usability, integrity and confidentiality of records maintained?
  • How are records managed whilst they are inactive (archived)? How is the reliability, authenticity, usability, integrity and confidentiality of records maintained?
  • What rules, policies and procedures does the CRO have relating to the creation of records, including use of appropriate metadate to facilitate retrieval and retention, and avoiding the creation of records that violate laws such as tax, competition and anti-discimination laws?
  • In what format are electronic records maintained? How is their long-term accessibility guaranteed?
  • Exactly how and when will records be transferred to the sponsor? In what format? On what media? At what time points? What quality control will be undertaken to ensure transferred records are of an acceptable quality?
  • How are records transferred internally within the CRO and between the CRO and other parties? How is the reliability, authenticity, usability, integrity and confidentiality of records maintained?
  • What is the process for destruction of records? What controls ensure that records are not prematurely destroyed? How will records under Legal Hold be secured?

Can you think of any more questions?

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About rammellel

Records management consultant to the life sciences / pharmaceutical industry
This entry was posted in Compliance, Records management practice. Bookmark the permalink.

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