Your study cannot start until pharmacy has looked at the protocol, set up internal procedures and documentation as well as organising stock delivery and storage.
A minimum of four weeks is needed but this may vary depending on the complexity of the trial and current workload.
Yes - for both commercial and some non-commercial studies. Please contact the relevant lead as soon as possible to identify what these costs will be. Pharmacy contact details can be found on the pharmacy registration pages of the study approval section.
All trial medicines must be issued by pharmacy, and unless there is a pressing clinical need or batch supply of an IMP, then all trial drugs must be stored within pharmacy
No. Preparation/dispensing of study medication can only take place Monday to Friday during working hours. Each department may have different cut off times for ordering study medication; this should be discussed with pharmacy during an initial meeting.
Note: Pharmacy is unable to prepare/dispense study medication after 5pm weekdays or at weekends
To comply with GMP and GCP an audit trail of the trial medicine's manufacture/ preparation, storage, prescribing, dispensing, administration and destruction is necessary. Usually pharmacy will generate those that relate to our activity.
Part of the CTA includes a description/copy of the label for the IMP. This must include all the criteria from Annex 13 (section 26) and once the CTA approval has been given then the label cannot change. Please check with pharmacy before submitting your CTA.