Conduct↦Management↦Responsibility and Oversight↦Drug Accountability
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.
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.
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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