To establish confidence in the results of clinical research, quality control in the execution of the protocol is an essential pillar. Quality control must guarantee the research results’ integrity, safety, and effectiveness.
What is quality control in clinical research?
Quality control is the set of procedures and activities carried out to ensure that the data generated during the clinical trial are complete, accurate, and consistent with the study protocol. This process encompasses several steps, including conducting the trial protocol, collecting and combining data in the database, analyzing data, and preparing the clinical trial report.
What are the current quality control guidelines in clinical research?
The current quality control guidelines followed by clinical trials are based on Good Clinical Practice (GCP), an international standard of ethical and scientific quality for designing, conducting, recording, and reporting clinical trials with human subjects.
GCP guidelines ensure that clinical trials are conducted safely and ethically, protecting the rights and well-being of study participants and generating reliable data. The guidelines cover all aspects of clinical trial design, including protocol development, data collection, monitoring, analysis, and reporting, as well as training and qualifications of trial personnel.
Compliance with GCP guidelines is essential for accepting clinical trial data by regulatory agencies and the scientific community, ensuring that the results can be used to make informed decisions about the safety and effectiveness of new treatments.
What are the objectives of quality control in executing a clinical trial?
- Data integrity: Clinical studies’ validity and reliability depend on the accuracy of their data. Quality control activities ensure the accuracy, integrity, and consistency of data collected throughout the trial.
- Safeguarding of research subjects: Protecting participants’ rights, safety, privacy, and well-being is essential.
- Regulatory and guideline compliance: Not only to maintain the integrity of the research but also to ensure that regulatory agencies accept the results.
- Adherence to protocol: Quality control activities involve monitoring and auditing processes in the execution of the clinical trial to identify any deviations or non-compliance with the protocol. Rapid identification of protocol deviations allows corrective action to be taken to maintain public and patient confidence.
- Improve the efficiency of clinical trials: Proper quality control helps identify and address potential problems in the research process before they become significant problems. These Guidelines also help improve the efficiency of clinical trials, reduce costs, and accelerate the development of new treatments and therapies.
What are the risks of quality control in the execution of clinical trials?
It is essential to implement strong quality control measures to mitigate these. A comprehensive risk management plan and ongoing monitoring are necessary to ensure the integrity and security of trial data. Some of the most critical risks are:
- Inadequate compliance with regulatory requirements and GCP guidelines
- Insufficient resource allocation to quality assurance activities
- Human error in data collection, documentation, or analysis
- Ineffective risk management. It includes significant security concerns, protocol deviations, or data integrity issues.
- Privacy and data security violations. Loss of confidential trial data compromises participant confidentiality and trial integrity.
- Inadequate training and communication.
- Regulatory changes.
How does Trial360 support quality control in executing a clinical trial?
- Trial 360 allows you to control the application of the protocol, for example, the scheduling of visits, window periods, the data captured in each visit, and laboratories to be taken in each visit.
- Trial 360 has the delegation log defined per study, including double authentication and security factors per user access, so the site users do what is expected.
- Trial 360 contains rules associated with GCP including, among others, the validation of participant data, avoiding duplicates or participants in more than one study at a time.
- Trial 360 allows you to configure different types of data, which is mandatory; in the case of a clinical laboratory, it will enable you to configure your reference ranges by age and sex of the participant.
- Trial360 allows you to have control over the execution of actions within the protocol, for example, not allowing actions to be carried out on the volunteer if they have not signed the informed consent, not allowing enrollment if they do not meet all the inclusion criteria and do not meet the exclusion criteria.
- Trial360 enables remote monitoring, encouraging remote quality control and reducing the need for on-site visits.
- Trial 360 allows you to control the application of the protocol, for example, the scheduling of visits, window periods, the data captured in each visit, and laboratories to be taken in each visit. Additionally, it includes the delegation log.
- Trial 360 has a module for managing findings and deviations that allows recording, monitoring, and managing findings.
- Trial 360 allows you to use different indicators for the volunteer, such as whether it is someone who finds it challenging to extract blood samples or whether it is a vulnerable patient.
- Trial360 has the PI Oversight that allows you to record, track, and manage reviews.
- Trial360 has an adverse events module that allows them to be recorded, monitored, and managed. Additionally, the person responsible will receive notification via email.
Questions about quality control in the execution of clinical trials?
References
Ibbott GS, Haworth A, Followill DS. Quality assurance for clinical trials. Front Oncol. 2013 Dec 19;3:311. doi: 10.3389/fonc.2013.00311. PMID: 24392352; PMCID: PMC3867736.
Velázquez I, Navarro X, Cobos A. Electronic data capture. Impact on the quality of the clinical research. Med Clin (Barc). 2004;122 Suppl 1:11-5. Spanish. doi: 10.1157/13057540. PMID: 14980154.
