Pharmacy SOPs

MODEPHARMA aids NHS pharmacy departments in the development, writing and implementation of Standard Operating Procedures (SOPs) for the handling of clinical trial medication. This service is highly relevant for NHS pharmacy departments that are experiencing a large uptake in clinical trial work as well as pharmacies wishing to review/update their existing SOPs to ensure compliance with GCP and current legislation.

Pharmacies involved in handling clinical trial medication are recommended to have a minimum set of written SOPs. Below is a list of some of the key SOPs that should be in place:

  • Contracts and financial agreements
  • Risk assessment and mangement
  • Setting up a clinical trial
  • Receipt and storage of study medication
  • Use of commercially available medicines from hospital stock
  • Labelling and re-labelling study medication
  • Preparation for a monitoring visit or audit
  • Return and disposal of study medication
  • Closing a clinical trial
  • Training of pharmacy staff

How We Go About It

The preparation of clinical trial SOPs is undertaken in a consultative manner with your pharmacy team. This involves observing and reviewing pharmacy operations as well as existing SOPs before the creation of customised clinical trial SOPs begins. For some SOPs, supporting templates will also be created to capture clinical trial data. Throughout the process, we involve your clinical trial staff to accurately capture what happens in practice and to improve staff awareness and compliance to SOPs.

The Benefits of Having In Place Up-to-Date Pharmacy SOPs for Clinical Trials

  • SOPs help to assure the quality and consistency of the clinical trial service;
  • SOPs based on up-to-date practices help to ensure that good practice is achieved at all times;
  • SOPs provide a contribution to the clinical trial audit and inspection process;
  • SOPs provide an opportunity to fully utilise the expertise of all members of the pharmacy team;
  • SOPs enable clinical trials pharmacists to delegate and may free up time for other activities;
  • SOPs help to avoid confusion over who does what (role clarification);
  • SOPs are useful for training new clinical trial staff members.

Contact us for further information or a no-obligation quote.