What is it? Why is it important?

In addition to ethics (EC) and regulatory (e.g. Swissmedic) requirements, institutions define internal policies that must be complied with during study planning and conduct.


A hospital can provide directives and/or guidelines on:

  • Medical confidentiality (e.g. data confidentiality
  • Data protection and secure infrastructure (e.g. processes for processing and sharing health related data)
  • Further-use of Biological Material (BM) and Health-related Personal Data (HrPD) (e.g. general informed consent procedures, Non-Disclosure Agreement (NDA), Data Transfer Agreement (DTA) for or HrPD, Material Transfer Agreement MTA for BM)
  • The development of data registries
  • Handling of biological material and biobanking
  • Insurance and legal policies (e.g. approval of study contracts, study insurance)
  • Corporate communication policies (e.g. publication of study results)
  • Restriction policies (e.g. restriction on the recruitment of study participants during a pandemic)
  • Study archiving policies
  • Quality control policies for internal institutional activities (e.g. study conduct, institutional audits)

What do I need to do?

As a SP-INV and Site-INV, familiarise yourself with institutional or hospital internal policies relevant to your study:

  • Search the hospital intranet for documents describing institutional policies
  • Sign-up for a training course where new institutional directives / guidelines are presented
  • Contact your legal department for established institutional processes and/or documents (e.g. general consent -, study contract agreements, NDA, MTA /DTA documents)
  • Contact your local CTU, who is knowledgeable about how to conduct studies at your institution. They can offer you valuable support and means on how to move forward


Before sharing health-related personal data and biological material with an external researcher, make sure that:

  • Participants have signed an Informed Consent Form (ICF) or a hospital general consent, confirming their agreement to share their health-related-personal-data (HrPD) or biological material (BM)
  • Ideally, a NDA is signed between SP-INV and external interested groups
  • A signed DTA / MTA is in place which defines conditions for sharing data and biological material

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • DTA – Data Transfer Agreement
  • HRpD – Health Related Personal Data
  • ICF – Informed Consent Form
  • NDA – Non-Disclosure Agreement
  • MTA – Material Transfer Agreement
  • SP-INV – Sponsor Investigator
Concept ↦ Ethics and Laws ↦ Ethics and Regulatory Requirements ↦ Institution Requirements

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Concept ↦ Ethics and Laws ↦ Ethics and Regulatory Requirements ↦ Institution Requirements

Please note: the Easy-GCS tool is currently under construction.