Smooth Drug Development provides services of clinical monitoring in clinical trials.
Our Clinical Research Associates (CRAs) have extensive experience in clinical trials. They receive regular training in ICH Good Clinical Practice (GCP) and the company's standard operating procedures. Most of our CRAs have medical, pharmaceutical or biological education.
According to GCP "monitoring is the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and the applicable regulatory requirement(s)".
Clinical monitoring is performed in accordance with the Clinical Monitoring Plan developed for each project. It covers all aspects needed for a CRA, such as frequency and schedule of visits, reporting procedures, training plan, project communication schedule, drug and accountability procedures. As per GCP, our CRAs visit investigational sites before, during and after the study.
Visits to the sites may be accompanied be the Sponsor. After each visit within a specified timeframe the CRA prepares a detailed visit report, which is reviewed and signed by the Project Manager, and then sent to the study Sponsor. The results of each visit are also summarized and sent in a follow-up letter to the Principal Investigator and site staff.
The main types of monitoring visits:
Site selection visits
Such visits are performed in order to assess whether the pre-selected site has everything to take part in the study.
During preparation for the visits the Project Manager defines the site evaluation criteria. As a minimum the following aspects should be taken into account:
- Correctness of the information provided by the site during the pre-selection
- Site equipment and facilities
- Requirements for site staff qualification
- The interest of the Principal Investigator in participation in the study
- Site administrative process
- Principal Investigator's access to study population
- Direct access to source documents and the practice of their maintenance
- Principal Investigator's and site staff experience
- Information about regulatory inspections and audits at the site
Based on the results of site selection visits the Project Manager and the Sponsor make a final list of sites for initiation.
Site initiation visits
Site initiation visits are performed before the patient enrollment start, when all the necessary approvals are obtained, contracts are signed, materials and investigational products are delivered to the site. During the site initiation visit the CRA makes sure that the site is fully prepared for the study, provides training on the protocol, study procedures, maintenance of source documentation, completion of the case report forms, collection of laboratory samples, checks the conditions of study drug and materials storage and the distribution of responsibilities between site team members.
Based on the results of the initiation visit the Project Manager approves start of enrollment at the site.
Site monitoring visits
Monitoring visits are conducted, as a rule, throughout the study, in order to monitor the progress of the study, to control study procedures, to verify study data, to document deviations and to provide additional training. The first monitoring visit is usually performed within 2 weeks after the first patient randomization at the site.
During these visits the CRA performs the following tasks to verify compliance with GCP and regulatory requirements:
- Checks all signed informed consent forms
- Checks the inclusion/exclusion criteria of subjects
- Checks enrollment progress
- Checks source documentation for accuracy and completeness
- Checks adherence to the protocol and registers deviations
- Verifies the data entered into CRF against the source documents
- Assist the site staff to answer the data queries
- Reports of missing data and the need corrections
- Checks reporting of adverse events
- Performs drug and material accountability
- Checks storage conditions of drugs, materials and biological samples
- Checks reporting to Ethics Committee
- Gathers updated documents to Sponsor file
- Checks Investigator's file
- Monitors the implementation of corrective actions
- Conducts training for staff when needed
In addition to site visits the CRA controls the course of the study remotely, according to electronic CRFs, central laboratory data and the documents sent from the sites. If necessary, we include In-house CRA to the project team, who performs remote monitoring and maintains site contacts between visits.
Site closure visits
Site closure visits are performed after all patients completed the study, all the data are entered and verified and all administrative matters are resolved. During the visit the CRA performs:
- Final review of Investigator's file and preparation for archiving
- The final accountability of the study drug
- Return or destruction of materials and investigational products