New Q&A for clinical trial sponsors regarding contractual arrangements with vendors for electronic systems

13 February 2017

The Good Clinical Practice (GCP) inspectors of the EU member states have published a new Q&A based on the pitfalls for sponsors to be aware of regarding contractual arrangements with vendors for electronic systems in connection with clinical trials. The Q&A is based on experience following inspection of sponsors and vendors and focuses on points which are frequently missing in contracts.

We frequently find important deviations in connection with inspections of vendors and sponsors, for example in the following categories:

  • Status of contracts
  • Distribution of tasks
  • Standards to be followed
  • Audits and inspections
  • Serious breaches
  • Compliance with the protocol
  • Output
  • Exemptions in contracts

More details about the types of deviations are given in the Q&A on the EMA’s website

The sponsor is responsible for ensuring that contracts are sufficiently detailed and cover the issues required to comply with legislation and guidance documents.