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IMP Management & Accountability

All pharmacy teams must adhere to GCP, the trial protocol, sponsor procedures and local policies1 to safeguard participants involved in clinical trials by ensuring that the medicines they receive are fit for purpose.  Responsibilities are delegated to sites through an agreement with the sponsor (i.e mNCA). A lack of pharmacy involvement in IMP management at site may result in inadequate record keeping, accountability and storage.

Trial specific procedures in regards to IMP management will be provided to participating sites by the Chief Investigator /study team (prepared in consultation with the dedicated clinical trial pharmacist).  IMP management and accountability will be monitored throughout the trial according to the study specific monitoring plan.

IMP will be released to sites (pharmacy) only when the sponsor is satisfied that all required approvals are in place (includes host site approval/NHS permission); this regulatory release of IMP maybe before or after a site initiation visit.  The site will be issued a study activation notice, upon receipt of this notice the site may commence the study.

Drug Accountability

Drug accountability allows for reconstruction of the trial – traceability of what IMP was received at site, dispensed to patients, returned and destroyed.  The level of accountability required for a trial will be assessed as part of the risk assessment by Noclor (in consultation with the clinical trial pharmacist). The trial specific drug accountability requirements will be proportionate to the IMP risk category A, B or C. 

Instructions and template accountability forms will be provided to sites as appropriate.  Although not a requirement of the Clinical Trials Regulations, it is good practice for IMPs to be prescribed on trial specific prescription form (paper or electronic). Where this is recommended for the trial (further to risk assessment by the clinical trial pharmacist) it will be mandated in the pharmacy procedures and a template will be provided to sites.

All prescribers for a clinical trial must be named on the delegation log for the study which should be retained within the Investigator Site File (ISF)

Storage & Destruction

It is imperative that IMP is stored correctly at all times to maintain its integrity (i.e ensure fit for purpose and safeguard participants).

Ideally all IMPs should be stored within the pharmacy department until the point of dispensing. In exceptional circumstances IMPs may be stored in other designated clinical areas, if required for the design of the trial and when approved by the sponsor. Where IMP is to be stored outside of the pharmacy department, the local pharmacy should have a formalised procedure for the assessment, approval and monitoring of the designated storage area and drug accountability records.

All parties involved at site should be aware of the storage requirements of the IMP and the action to be taken in the event that the conditions are not met (which will usually be stated in the trial specific pharmacy procedures provided by the Chief Investigator/study team (in consultation with the clinical trial pharmacist)). 

The site pharmacy should have a process in place to identify and manage temperature excursions in relation to on-site storage of the IMP which will include how affected stock will be quarantined (in a segregated area) and how the sponsor will be notified.  Failure to act on temperature excursions can have serious consequences (refer to serious breaches).

Any IMP returned to pharmacy should be segregated from unused stock to avoid inadvertent use.

Unissued IMPs and returned used IMPs (returned by clinical trial subjects) will usually be disposed of locally on sponsor authorisation, in accordance with the sponsor's instructions and Trust procedures.  Arrangements for disposal should be agreed during set-up of a study to ensure any cost implications are considered.

IMP Recall

The responsibility for IMP recall lies with the sponsor.  However, IMPs and or comparators that are authorised products will be recalled by the Marketing Authorisation Holder (MAH) and the sponsor will be notified indirectly by the supplier.

The decision about whether to initiate a recall will usually lie with sponsor (Noclor will act on the advice from the dedicated clinical trial pharmacist on the trial). 

A host site is not required to have a separate procedure for clinical trials, as the local Trust Medicines Management Policy should cover retrieval of unused supplies from wards and contacting participants for dispensed products.

[1] The Medicine Management Policy at each Trust should provide guidance to staff about the requirements and processes for prescribing, storing, manufacturing, dispensing, administration, return and destruction of investigational medicinal products for use in clinical trials