Good Clinical Practices in compliance with SOP’s
Understanding the SOP and its need
As Judith Martin said, “Freedom without rules doesn’t work. And communities do not work unless they are regulated by etiquette.”
Those set of rules are SOP. Standard Operating Procedure is an arrangement of instructions compiled by an organization to help workers carry out complex routine operations with efficiency, quality output and uniformity of performance while decreasing any miscommunication and failure to manage with industry regulations. It offers detailed information that describes how to perform a routine activity. It helps in maintaining efficiency and safety in all the departments including production, sales and customer service, employee training, legal and financial. The purpose of this SOP is to explain the staff and other members the procedure for logging and resolving complaints.
SOP can be beneficial as they not only save time and money but provide consistency. They even improve communication by letting every person know their job and no longer be in a confusion of the actions and decisions he can make. This way, they even allow you to hold your employees accountable. Lastly, they create a safer work environment as there will be no accidents and work will be done consistently.
GCP and its importance
Good Clinical Practice (GCP) is an international scientific and ethical quality standard for conducting, designing, reporting and recording trials which involves the participation of human subjects. In Compliance with the following standard it provides public assurance that the safety, well-being, and rights of the subjects are consistent, protected with the principles that have their origin in the Standard Operating Procedure, and that the clinical trial data is credible, along with the credibility of the source depends upon the reputation and accuracy of the date.
There are 12 most essential components of GCP
- Qualified Investigative Personnel/Sites – The investigator should have qualifications and competence in accordance with regulations and laws as evidenced by an up-to-date curriculum, be experienced in clinical trial research methods, be aware of available relevant literature and all information provided by the sponsor; have access to human and other resources to assume full responsibility for the appropriate execution of the trial.
- Informed Consent and Stroke Trials– The information should be provided in a clear oral and written form with 100% understandability of the subject. No obligations must be implied on the subject for the participation of the trial. The insurance information shall be accessible to the subject.
- Safety Reporting– This includes identifying the institutional expectations for reporting safety information for a protocol which is locally reviewed and also by the central agency. The sponsor must inform the investigator(s) promptly of any immediately relevant information on safety that becomes available during a clinical trial and ensures that the ethics committee and the drug regulatory authority are notified by the investigator(s) if required.
- Privacy and Confidentiality – it is vital to Identify specific institutional practices for managing the subject collected for research and to describe if there are State/local specific privacy laws regarding the management of the subject(s) collected for research
- Handling of Investigative Products– The sponsor should appoint appropriate individuals and/or committees for managing and supervising the clinical trial, handling and verifying the data obtained, statistical processing, and preparing the trial report.
- Maintaining Data Quality– The sponsor must appoint suitable and appropriately trained monitors and clinical research support personnel, and provide ongoing training to ensure that they are suitably qualified an to keep them up to date with new developments.
- Laboratory Reliability and Quality Assurance– The sponsor should establish a system of quality assurance to ensure that the conduct of the clinical trial and the generation, documentation, and reporting of data comply with the protocol, Good Clinical Practice standards, and applicable regulatory requirements
- 8. Site Performance Monitoring – Provide the institutional process/policy (contact persons) for establishing: • site initiation and training visits • site source data verification monitoring visits • site network performance visits and audits • site study closeout
- Trial Recruitment– The sponsor should appoint appropriate individuals and/or committees for managing and supervising the clinical trial, handling and verifying the data obtained, statistical processing, and preparing the trial report
- Per Subject Payment– it includes a description of policies for the payment of subject research-related expenses and any agreements detailing personnel and/or patient care reimbursement agreements by the sponsor.
- Data Maintenance and Storage– • The process for collection and maintaining trial specific regulatory documents-Trial Specific compliance checklist, internal and external review of trial specific regulatory documents, archiving trial specific original signed and electronic regulatory documents are essential.
Important features to be mentioned in Standard Operating Procedures (SOPs) in Clinical Trials.
In compliance with GCP, Standard Operating Procedures (SOPs) are the standard documents which define the procedures, that assures the conduction of research under regulations. The SOP(s) help the research teams, as recommendations for researching appropriately. They clearly outline the procedures to be followed on a number of topics concerned with clinical research.
The most primary SOP to be made should help in preparing, maintaining, numbering and formatting SOPs. It should help the research team to prepare SOP’s that comply with the guidelines set by GCP and FDA.
Then, the SOP should define the responsibilities of the research team, that all conditions defined by the FDA on the use of investigational articles are followed. The principal investigator should be the head of the team and be responsible for implementing the guidelines.
SOP made on training and education helps defines the standard training procedures which must be adopted to assure the responsible clinical research. The purpose of this SOP is to prepare guidelines for good clinical practice in compliance with the FDA.
All trials need to comply with certain scientific and ethical procedures. The SOP will help in determining the feasibility of protocols in a trial and also setting up protocols that can take care of medical, regulatory and ethical requirements.
Finally, SOP should mention steps to help the sponsor analyze the study site in view of facilities, implementation, and feasibility.