What is it? Why is it important?

Drug/Device Accountability (DA) refers to the documentation regarding the management and handling of a study IMP/MD. Both SP-INV and Site-INV(s) are responsible for its documentation.

DA records or logs:

  • Help to keep oversight over product handling during study conduct (e.g. incoming orders, products used by participants, expired and destroyed products)
  • Provide proof that IMP/MD, including any placebo or comparator, was handled and administered according to the study protocol, GCP, and applicable regulatory requirements
  • Are reviewed during study monitoring or RA inspections.

More

All studies using an IMP or MD in their study are required to maintain ongoing product oversight.

  • For the SP-INV, accountability starts upon product ordering or its manufacturing, until distribution to study site or destruction. Timing of destruction might include the end of a required archiving period.
  • For the study site IMP/MD accountability:
    • Starts when the IMP/MD is received by the site
    • Is accounted for when dispensed to and returned by participants
    • Is checked by the monitor. Empty blisters or bottles should be kept until the monitor has finalised the accountability control
    • Ends once returned to SP-INV for destruction of potential left-overs.
  • At a study site, the Site-INV carries main accountability responsibilities. The Site-INV can delegate accountability duties to a pharmacy or study staff. Still, responsibility remains with the Site-INV.

What do I need to do?

As a SP-INV, implement accountability procedures and document:

  • IMP/MD ordered and received by licensed provider (e.g. pharmacy, manufacturer)
  • IMP/MD distributed to study sites
  • Any stability testing of expired IMP/MD
  • Returned IMP/MD aimed at destruction

As a Site-INV, ensure ongoing documentation of product inventory, such as:

  • Log any IMP/MD received by SP-INV
  • Log any IMP/MD given to and returned by participants
  • Check for any expired IMP/MD and if applicable:
    • Send expired IMP/MD for stability testing
    • Relabel IMP/MD based on newly approved expiration
  • Return expired IMP/MD to SP-INV or destroy based on SP-INV SOPs.

For more information refer to Drug or Device in this Study Guide.

More

IMP/MD oversight also includes:

  • Collaboration with IMP/MD provider (e.g. MAH, pharmacy)
  • Documented monitoring of IMP/MD by only allowing access to delegated staff members. This ensures that accountability status remains current and correct.
  • Faultless condition of IMP/MD upon dispensing to participants, (e.g. IMP/MD preparation, labelling information, removal of damaged IMP/MD, faultless execution)
  • If applicable, ongoing correct administration to study participants, (e.g. dosage escalation, adaptations)
  • Ongoing documentation of storage conditions in order to ensure and prove correct IMP/MD storage as described in the study protocol and or package insert (e.g. temperature, humidity, light, fire protection)
  • Destruction methods used for IMP/MD destruction including its confirmation
  • Training of staff responsible for the management and handling of study IMP/MD

Where can I get help?

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

References

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 - see in particular sections (access liable to cost)

  • 7.9 Investigational device accountability
Abbreviations
  • CTU – Clinical Trials Unit
  • DA – Drug/Device Accountability
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP - Investigational Site File
  • IMP/MD – Investigational Site File / Medical Device
  • 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 Accountability
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): Conduct ↦ Management ↦ Responsibility and Oversight ↦ Drug Accountability

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