What is it? Why is it important?

Drug and Device Accountability (DDA) refers to the documentation and management (e.g. shipment, storage, preparation, use, destruction) of an Investigational Product (IP) (e.g. an IMP and/or IMD).


For a SP-INV, IP accountability:

  • Starts once the IP is ordered from a Manufacturing Authorisation Holder (MAH), followed by the distribution to participating study sites
  • Ends with IP destruction, which can also be the end of a required archiving period


For a Site-INV, IP accountability:

  • Starts once the IP has been delivered to the study site
  • Continues to be tracked during study conduct, such as when the IP is:
    • Removed from storage, or prepared and delivered by a hospital pharmacy
    • Distributed to study participants
    • Returned by participants to the study site (e.g. compliance check)
  • Ends with used / not used IP being returned to the SP-INV or destroyed at the site


IP oversight also includes a:

  • Collaboration with IP providers (e.g. MAH, pharmacy)
  • Faultless storage of IP based on IP instruction for use, and SP-INV specifications (e.g. required storage temperature, humidity, light)
  • Restricted access to IP-storage sites (e.g. study site delegation-log). This ensures that the DDA-log remains current and correct, and IP is protected against accidental loss or damage
  • Faultless IP dispensing to study participants (e.g. IP preparation, IP labelling information, IP dosage escalations, removal of damaged IP, faultless execution)
  • Faultless ongoing IP documentation. This includes the proof that any placebo or comparator was handled and administered according to the study protocol


DDA-logs are subject to reviews during study monitoring visits, and potential RA inspections (e.g. Swissmedic).

What do I need to do?

As a SP-INV, implement DDA procedures and document IP:

  • Ordered and received by licensed providers (e.g. pharmacy, manufacturer)
  • Distributed to study sites
  • Use during study conduct (e.g. based on the monitoring of IP use by study participants – used/not used)
  • Expiration and any stability testing during study conduct
  • Returned from participating study sites, including its destruction


As a Site-INV, maintain ongoing oversight of IP-Inventory and use. Document ongoing:


As a Site-INV, manage IP storage, such as to:

  • Ensure ongoing optimal storage conditions
  • Check for expired IPs and if applicable:
    • Send expired IPs for stability testing
    • Relabel IPs based on a newly approved expiration date
  • Return unused or expired IPs to the SP-INV, or destroy IPs based on SP-INV SOPs


As a Site-INV, during study conduct:

  • Keep empty IP blisters, vials, or bottles until the study monitor has documented its use. This information enables the SP-INV to perform IP accountability controls during study monitoring visits (e.g. use is tracked based on which study participant received and used which IP lot/serial number)
  • In the event IPs are destroyed at the study site, provide the SP-INV with a certificate of destruction


IP accountability ends upon IP destruction, implemented after a required archiving period

Where can I get help?

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


ICH GCP E6(R2) – see in particular guidelines

  • 4.6 Investigational product(s)
  • 5.14 Supplying and handling investigational products(s)
  • 8.3.23 During the Clinical Conduct of the Trial

ISO 14155:2020 Medical devices (access liable to cost) - see in particular section

  • 7.9 Investigational device accountability
  • CTU – Clinical Trials Unit
  • DDA – Drug and Device Accountability
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IMP – Investigational Site File
  • IMP/MD – Investigational Site File / Medical Device
  • IP - Investigational Product
  • ISO – International Organization for Standardization
  • MAH – Manufacturing Authorisation Holder
  • MD – Medical Device
  • RA – Regulatory Authorities
  • SOP – Standard Operating Procedures
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
Conduct ↦ Management ↦ Responsibility and Oversight ↦ Drug and Device Accountability

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): Conduct ↦ Management ↦ Responsibility and Oversight ↦ Drug and Device Accountability

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