The conduct of clinical trials is forever growing; however there is still a need for new research sites to assist in conducting clinical trials. Most of the Doctors who are interested to join this fascinating and ever growing industry might be asking this question: “What are the basic requirements for a site to be selected for a conduct of clinical trials?”
Here is a brief guideline of the basic requirements we evaluate when assessing for the site’s eligibility to conduct trials:
1. Investigator and Staff qualification:
- Are the investigator/staff qualified by education/training/experience to conduct the trial? I.e. GCP trained, experience with Clinical trials, Therapeutic area, Subject population, IP/similar products. Please note not all site staff has to have experience, at least the investigator should have conducted other studies as a sub-investigator.
- Availability of a qualified physician that will be responsible for all trial-related medical decisions and protect the rights/safety/welfare of subjects and provide reasonable medical care to subjects for study-related conditions.
- How the investigator will coordinate study activities i.e. will the investigator designate a research coordinator for the study?
- Do the investigator and staff have adequate time and availability for the conduct of the study, including availability for the monitoring visits?
- The investigator has to understand the responsibility to adequately supervise the trial - delegate tasks to qualified staff, give staff training, supervise staff/third parties, develop study oversight plan.
- The investigator and staff must have adequate language capabilities to understand study documents and procedures (protocol, CRF, lab manuals etc.)
- The site staff needs to understand their obligation to allow regulatory agency/other third-party inspections.
- The investigator (or other appropriate staff) should be available to attend an investigators meeting.
- Does the site have an internal QA/QC process in place.
2. Facilities and Equipment and Calibration records:
- The investigator to provide adequate facilities to accommodate the trial, including space for monitoring, access to a phone, fax, copier, and internet.
- The investigator should have a computer/high speed Internet connection which can be used for EDC data entry/for monitoring, If not, the investigator should be willing to arrange a high speed Internet connection.
- The personnel responsible for shipment of hazardous goods/dangerous materials must complete training as required by regulations.
- If the site will be using a local laboratory, the laboratory has to be certified, accredited, or has an established quality assurance program.
- Weight, Height scales, Blood Pressure Apparatus, Thermometers, ECG machine, Centrifuge, Fridge and Freezers-20°C, -70°C and -80°C freezer.
- Availability of uninterrupted power supply / back-up generator.
- Emergency Trolley, Equipment (oxygen &resuscitation) and checklist-expiry dates on vials and drugs.
- Equipment calibrations should be performed using standards traceable to certified standards, if existing.
- Records of these calibrations should be maintained.
- Access to emergency facilities.
3. IP / Study Supplies:
- The investigator has to identify the location & responsible person for the secure storage/dispensing of IP in accordance to GCP/applicable regulation.
- They need to make sure that access to IP is limited to study personnel only.
- The subject sample collection procedures, processing equipment and storage requirements have to be in accordance with GCP/applicable regulations.
- The site should have appropriate temperature monitoring and control systems for IP storage (e.g. appropriate power supply alarm/back-up if required).
4. Documentation Procedures:
- Source documents (including their typical content) should be adequate/in compliance with local regulations/GCP/GDP.
- The investigator and staff must be willing to comply with minimum standards of source documentation (attributable, legible, contemporaneous, original & accurate).
- If electronic source records will be used, the investigator must agree to provide to the monitor either read-only access or printed certified copies of the electronic records.
- The site should have adequate storage for paper/electronic records retention required by regulations/GCP/client.
- The investigator and staff must agree to comply with regulatory documents requirements.
- The site will be responsible for archiving Study documents and record protection and retention.
- The site should have SOPs in place i.e. IP- Receipt, dispensing, destruction etc… ICF administration, Clinical data management, SAE/AE Management, subject recruitment, retention and follow up, maintenance of Source documents / electronic source documents, Supplies, Calibration of equipment, etc.
5. Patient Population:
• Demonstrate that suitable subjects can be recruited-GCP requirement.
• Computerized diagnostic index (database), specific clinics, referrals, etc.
• Other competing trials at site-end up with two dissatisfied sponsors.
• Ability to complete trial within the agreed period.
6. EC requirements:
- The site need to be affiliated to the EC to submit their Protocol to for the protection of the patients or submit to the institutional EC.
- Notify EC on study progress.
- Needs to understand and comply with the EC requirement.