What is it? Why is it important?

In addition to ethics and regulatory 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
  • Data protection and secure infrastructure (e.g. processes for processing and sharing health related data)
  • Further use of biological material and health-related personal data (e.g. general informed consent procedures, NDA and MTA)
  • 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?

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 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

More

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

  • Participants have signed an ICF or a hospital general consent, confirming their agreement to share their health-related-personal-data (HRpD) or biological material (BM)
  • Ideally, a Non-Disclosure Agreement (NDA) is signed between SP-INV and external interested groups
  • A signed DTA (for HRpD) MTA (for BM) 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

Abbreviations
  • 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 ↦ Study Planning ↦ Institution Requirements
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

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

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