Properly equipped laboratories are essential for the conduct of scientific research. CHRU’s laboratories allow researchers and scientists to carry out trials in accordance with international best practice. The laboratories are run according to Good Clinical Laboratory Principles (GCLP) and provide services including handling, testing, storage and staff training.

Samples are stored at this site in -70-degree freezers, and are logged using a laboratory information management system prior to the preparation of batched shipments for testing at external laboratories.

The operations of the laboratory are made up of different processes. These include:

• Internal quality assurance to benchmark the efficacy of the tests, kits and equipment used by the laboratory
• External quality assurance to ensure the laboratory runs tests with results that are within an acceptable median range
• Participant sample collection
• Processing and testing of samples
• Issuing of laboratory reports
• Shipment of samples to both local and international laboratories, a process which involves ensuring the integrity of samples and is conducted in accordance with the international standards.
• Bio-hazardous waste management
• Training of research staff in using protective equipment, how to perform tests for protocols, etc.
• Sample storage facilities in the fridge/freezers
• Maintenance of sample integrity with 24-hour monitoring of freezer and fridge temperatures and
• Specimen rejection and retention.

A complex infrastructure underpins CHRU’s sites comprising physical infrastructure, clinical rooms and facilities, specialised equipment, information technology (IT), communication technology and rigorous security throughout.

Water- and fire-resistant archive rooms house source documents with trial participants’ details, tests, results, records, etc. Each source document is also transcribed into a Case Report Form (CRF) which is maintained for the full duration of the study. CRFs are kept in both printed and electronic formats and are used to collect and retain the data as described in the protocol for each trial. CRFs allow investigators to report the specific data collected during the trial. Data is recorded continuously to uphold compliance with the protocol. At the end of each trial, the CRF is completed and signed by the investigator.

Files are retrieved and stored on a daily basis necessitating rigorous quality control to retain the integrity and accuracy of all participant information. Each participant file is assigned a unique number which stays the same, even if the participant takes part in another trial.

A centrally-controlled time clocking system is maintained at the unit which all staff must adhere to. Timing is critical in ensuring the integrity of studies and manage participants correctly.

Study coordinators at CHRU are responsible for day-to-day running of the clinical trials the unit runs. They have a range of responsibilities that they must fulfil meticulously at any one time as they work with multidisciplinary teams and trial participants. Participant care is a key role for CHRU’s study coordinators which involves:

• Good clinical management of participants
• Follow up of any medical conditions eg laboratory results
• Anticipating participants’ needs
• Educating participants on the disease process and study protocol
• Ensuring participant confidentiality at all times
• Building a good rapport with participants and
• Respecting the diverse cultures of CHRU’s participants.

Medical officers or Principal Investigators (PIs) are responsible for the preparation, conduct and administration of a research grant or sponsored project.

They have a leadership role at CHRU to ensure that the research takes place in compliance with the required regulations including Good Clinical Practice (GCP) and according to the institutional policy governing the research.They are key players that ensure CHRU’s clinical trials are carried out according to the research study protocol.