Implementing Systems for Data Quality and Clinical Documentation in the Pharmaceutical and Biotechnology Industry

The practice of implementing standards and systems within a health care organization has evolved over the years. As a result, the scope of responsibilities has broadened. As this has occurred, there are some important changes that need to be made to ensure the continued success of a quality business.

A quality improvement program that focuses on quality must target two key areas: quality improvement management and clinical quality improvement. It is the goal to improve the quality of care delivery while reducing administrative costs. The first area addresses the systems and policies that are employed by a facility. Institutional policies must include policy directives and procedures on patient privacy, recordkeeping, quality assurance, use of clinical information, and compliance with statutory and regulatory requirements. These policies may include rules on pre-authorization and post-authorization requirements. Institutional quality management focuses on issues such as quality assurance, regulatory submission, scope, and case management.

Clinical quality involves an internal medical writing group that reviews the documentation provided by in-house and out-of-house medical writing groups. Both independent and inter-disciplinary group meetings are held to address issues and problems in the documentation. At the end of the meeting, a final study report is presented with recommendations on improving the quality of documentation. This final study report is usually released in January/February of each year.

In addition to final study reports, there are formal audits conducted within the organization to evaluate the overall quality of in-house and clinical documentation. In-house audits are usually conducted by an independent clinical quality authority, whereas independent audits are generally done by outside consultants. In addition to audits, there are many cases where the clinical documentation is sent to outside review boards and investigators to be reviewed for quality assurance.

One of the most significant areas that can suffer from poor quality clinical documentation is the conduct of central lab testing including blood drawings, stool samples and other specimen collection forms. These forms should be perfectly documented and accurate for every sample taken. The documentation should have no missing information and consistent throughout the year. For this reason, it is extremely important to implement quality improvement programs for central lab testing. The programs should include written quality directives, periodic review and audits, post-test audit meetings and more. The central lab testing service for clinical trials can help improve the quality of documentation, while also ensuring that the laboratory services perform according to established guidelines.

There are many cases when the clinical study documentation will need to undergo revisions. Cases include changes to the treatment plans, modifications to the sample collection forms, changes to the data collection forms or to the data reporting policies and procedures. When implementing standards and systems for quality assurance for the laboratory services, the organization needs to consider the impact these changes will have on the quality of the service and the data collection as well as the quality of the completed test and the results.

Another area that can suffer from poor quality control is the quality of the pharmacovigilance staff’s work. The pharmacists and the staff should adhere to documented quality principles and practice continuous quality management activities including adequate training, supervision, adequate supervision and record keeping. These activities will help ensure compliance with good quality standards. The use of electronic health records will also provide an opportunity to track quality parameters and to make frequent quality checks. The primary objective of implementing standards and systems for the quality of pharmacovigilance is to reduce errors in treatment and increase the safety of the study population.

The quality of the quality control process for clinical pharmacology should include a set of quality objectives for the entire staff. These objectives and goals should be designed for the entire staff and not just for specific areas or personnel involved in the clinical documentation or in the drug design or delivery. The quality plan should include a proposal for meeting the specific requirements, timelines for achieving the objectives, and the consequences for failure to meet the goals. Other criteria that might need to be considered in determining the success of implementing standards and systems for data quality and for the quality of the films performed are the size and type of the institutions, the number of staff involved in administering the cioms and the number of times the rooms are performed.