CTIMPs & CIMDs
If your research involves a Clinical Trial of an Investigational Medicinal Product (CTIMP) subject to the Medicines for Human Use (Clinical Trials) Regulations or a Clinical Investigation of a Medical Device (CIMD) subject to the Medical Device Regulations, ACCORD will assign a Clinical Research Facilitator to support you and assist with protocol development, preparation of documentation, sourcing investigational supplies, contracts etc.
Approval from the Medicines and Healthcare products Regulatory Agency (MHRA) is required for all CTIMPs and for CIMDs where the data may be used to support CE marking. Your Clinical Research Facilitator will assist with the submission. Submission to the MHRA incurs a fee depending on the type of trial or investigation.
Further information can be found here for CTIMPs and here for CIMDs.
ACCORD will ensure you and your study team receive appropriate training before your study commences. This normally involves attendance at a local Good Clinical Practice (GCP) course, and one-to-one training with the relevant ACCORD SOPs.
ACCORD performs a risk assessment of all CTIMPs and CIMDs, focussing on the nature of the investigational medicinal product or device, the product's known safety profile, the type of study (phase I, II, III or IV), the vulnerability of the participants, complexity of the protocol, experience of the research team etc. At the end of the risk assessment meeting, you will be invited to join the meeting to discuss the mitigation of any risks that are identified.
Monitoring and Audit
A monitoring plan is determined based on the outcome of the risk assessment. ACCORD monitors perform a site inititation visit (SIV), routine monitoring visits according to the plan and a close out visit. Occasionally, triggered monitoring visits may also be required.
ACCORD Quality Assurance (QA) may perform a study or facility audit.
Monitoring and QA visits are a valuable opportunity to ensure your study is compliant with the protocol, SOPs and applicable regulations and to ensure the study data are accurate and verifiable. ACCORD monitors and QA can also provide support and answer any questions you may have throughout the conduct of your study.