Successful Monitoring of Clinical Trials: SOP Writing & Staff Training Aspects
An ideal situation for the pharmaceutical company regarding the conduct of a clinical trial is to assure safety of its participants and accuracy of its results. In addition, all necessary efforts should be taken to avoid any kind of delays with the completion of the trial. Successful and rapid completion of a clinical trial leads to rapid marketing of a new pharmaceutical product which in turn assures profit margins for the pharmaceutical companies.
All clinical trials conducted with the participation of human patients are to be monitored. The method and degree of monitoring depend on degree of risk involved in participation, as well as scope and complexity of the clinical trial. Regardless of the methods used, monitoring should be conducted on a regular basis. The main goals of monitoring are to assure adequate protection of the rights of human subjects and the safety of all subjects involved in clinical investigations and the quality and integrity of the resulting data. So while planning a clinical trial and designing the protocol, monitoring plan should be considered very carefully to assure adequate fulfillment of its tasks. This article will give the general idea about the nature of monitoring and its role on conduct of clinical trials.
The nature of clinical trials monitoring and its main requirements
Peopleā?Ts health is the most important thing in any time and in every society. So while developing drugs for people a lot of efforts should be done to avoid any mistakes and misconducts.
Sponsor or the designers monitor the progress of a clinical trial. A Sponsor selects different procedures for monitoring clinical trials and these procedures may be reviewed by Food and Drug Administration.
One or more individuals with appropriate qualification should be assigned to monitor the progress of a clinical trial. A monitor should have enough knowledge, training, and education; be able to travel, possess good communication skills.
While choosing a monitor for a clinical study the following is to be considered:
– the number of investigators participating in a study
– the number and location of the facilities
– the type of drug involved
– complexity of the study
– the disease or condition being studied
Before a clinical trial is initiated, the monitor should conduct a pre-study visit to check if investigator understands the nature of the study, its procedures, requirements, his/her obligations; able to enroll certain number of patients, has adequate facilities, accepts to follow protocol and regulatory requirements.
In the course of the study a monitor conducts periodic visits to sites to assure that the investigator fulfills his/her obligations and the facilities continue to be acceptable, study protocol is followed; to check patients safety, accuracy of the study data and records, regulatory requirements are met.
To assure the accuracy of the study data the individual patients records and other source documentation should be reviewed and compared with the reports prepared by the investigator. Thus, during a monitoring visit the monitor is to compare a number of patient records and other source documentation with the investigatorā?Ts reports and to determine that the recorded information is complete, accurate and legible, there are no omissions, missing visits or examinations, informed consents have been properly documented.
After each visit a monitor should prepare a monitoring visit report, which reflects the full situation at the site: findings, conclusions, any actions taken to correct any deficiencies noted during the visit.
Writing Standard Operation Procedures
Conduct of clinical trials is a very complicated activity. It is regulated by GCP-ICH requirements and other applicable laws; concern of protecting the safety and welfare of patients participating in a study. During the conduct of a clinical trial the principle investigator, project manager and a monitor must use a written policies and procedures describing the monitoring and reporting procedures.
Study investigators must follow a protocol exactly and meet other sponsor demands.
Standard Operation Procedures (SOP) is a document designed for the study conduct and used by certain Clinical Research Organizations or Sponsor companies while conduct of the procedures for clinical trials. Before a study is set up a Sponsor should consider which SOPs will be used for this study. SOPs describe all study related procedures and these procedures are to be performed in comply with the agreed with a Sponsor SOPs. It is requested that SOPs comply with the principles of ICH-GCP, FDA (if applicable) and any local regulatory requirements.
SOPs are critical tools in successful business operations for all those involved in doing clinical trials, including investigative sites, sponsors and IRBs. They are essential for standardizing processes, for ensuring that regulatory and organizational policy requirements are met, for training new personnel and for managing workload.
It is very important for SOP to be understood by all clinical trial staff. Thus, certain requirements as for its writing are met and the following considered:
– the title must be descriptive
– date when the SOP became operative is to be specified
– the edition number and a statement that this edition replaces an earlier edition from an earlier date
– the exact distribution of SOPs
– the signature of the person responsible for writing the SOP
– the signature of the person responsible for authorising the SOP
To make the SOPs clear for those who work with them, author should use easy language, detailed explanation of all steps, convenient format. The SOP must be located in a place with an easy access.
Training is also very important part of any clinical trial. All members of a clinical trial should be aware of how to use SOPs, have some kind of medical training depending on the therapeutic area, of a tested drug, be instructed on logistic aspects, etc.
According to ICH Good Clinical Practice Guidelines, it is required that Investigators and other study staff working on a clinical trial are qualified by training and experience to undertake their relevant roles and responsibilities.
A record of the members of staff working on a clinical trial is kept within the Trial Master File, using the sponsor approved Staff Authorization and Responsibilities List.
A record of the relevant training for each member of staff undertaking work on a clinical trial must also be kept, in line with the Staff Training Record SOP.
Any clinical trial is to be audited by the Quality Assurance department to ensure the study is conducted properly, and all study related documents are recorded and maintained correctly. Quality Assurance department provides audit to evaluate clinical research activities for compliance with the study protocol, all applicable regulations, guidelines and standard operation procedures.
Clinical quality assurance department periodically reviews SOPs, oversees a distribution of the SOPs, all the staff is trained to use the SOPs.
Clinical quality assurance department conducts audits during which whole set of study documents are checked for any mistakes, discrepancies, omissions, frauds, if any, deviations from SOPs and a study protocol.
Adequate monitoring and appropriately composed SOPs are able to prevent timely any delays, occurring of serious problems, and any significant inconveniences, which may affect the whole process of the new drug development. Such a simple thing, as it is seen from the first sight, plays a very important role in this complicated structure of the drug development.
FDA Oversight of Clinical Investigators
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
Ethical Principles for Medical Research Involving Human Subjects