Good Clinical Practice, Research Paper Example

Good Clinical Practice (GCP) supports the development of clinical trials that address the moral and ethical responsibility that is associated with clinical research in order to protect patients from unnecessary risks or harm. GCP encompasses areas that are of clinical importance in order to properly conduct clinical trials in a manner that is consistent with moral and ethical standards associated with research. This includes areas such as the protection of human subjects, ethical design considerations, and the accuracy of data as identified in the study. GCP has wide-ranging applications that demonstrate the importance of maintaining ethical responsibility at all times when conducting clinical trials across a variety of subject areas. GCP not only involves investigators and key personnel who conduct clinical trials, but also those who develop and manufacture pharmaceuticals, as well as those who govern and regulate research. The creation of GCP demonstrates the importance of maintaining ethical approaches to improve outcomes associated with clinical research across all subject areas.

Good Clinical Practice also supports ethically responsible laboratory practices and the protection of data as required to ensure that investigators adhere to established guidelines so that clinical research is safe and appropriate. Governing bodies regulate clinical research so that patients are not compromised at any stage of a clinical study. In addition, GLP supports the protection of confidential data as required so that patient information is not compromised. These efforts are important because they provide clinical researchers with an environment that is conducive to safe and ethically responsible research practices at all times. Many significant regulations have passed in recent decades that serve in supporting clinical research and the protection of human subjects and related data so that there are no unnecessary risks involved in these studies. In addition, organizations such as the Food and Drug Administration (FDA) are responsible for regulating clinical research so that maximum precautions are taken to protect subjects from risks that could be prevented under safe and effective research practice methods. In the modern era, clinical trials are managed using technology-based tools; therefore, it is necessary to establish protections within these tools to ensure that patient data is not compromised in any way. GCP also includes such areas as informed consent, institutional review boards, financial conflict of interest, investigational new drug (IND) regulations, HIPAA, and Public Health Information (PHI). These focus areas are instrumental in supporting the requirements associated with Good Clinical Practice in order to achieve safe, effective, and ethically responsible clinical research at all times.

Data Collection Methods

Data collection involves the development of research methods to identify the type of data that is necessary to conduct a study and to develop research methods that will be effective in supporting study objectives. One type of data collection method that is common in clinical research is the Case Report Form (CRF), which allows clinical researchers to collect data regarding study participants onto a single form and to determine if the data is effective in addressing the chosen hypothesis. CRFs are commonly used throughout clinical research studies to determine if the chosen method, such as a study drug, has led to the desired result within the selected population group. This information supports the researchers in determining if the expected outcomes are able to be achieved. In many clinical studies, paper CRFs are the chosen format because they enable the clinician to collect data as necessary and then use a data entry method at a later date to input the data into a database format. However, paper CRFs may lead to transcribing issues or other concerns that are difficult to control, thereby leading to the possibility of erroneous data that could distort the final outcomes. Therefore, paper CRFs must be used carefully and thoughtfully during the data collection process.

The use of electronic methods to collect data have also become increasingly common in recent years, particularly with the availability of tablet computers and other mobile technologies to collect data without difficulty. However, as with any electronic system, confidentiality may pose a problem if the chosen system is not secure, as well as the possibility of loss of data if the server crashes. Therefore, it is necessary to consider the options that are available to researchers in order to maximize the integrity of data at all times. In some cases, a combination of methods are used to ensure that data collection is as accurate as possible. It is also important to consider the use of data as collected through central laboratories so that this data is not compromised. As a result, confidentiality and randomization are often considered to be viable options so that the data is protected at all times. Each of these alternatives is governed by a number of different agencies so that human subject data is protected and secured as best as possible, using ethically responsible approaches.

Data Management Issues

Managing data within a clinical research environment requires an effective understanding of the elements, both expected and unexpected, that might occur in order to determine how to best move forward with a study in a manner that is safe, protected, and ethically responsible. Data management in clinical research encompasses a number of areas that are important and necessary in supporting effective outcomes for a given study. Therefore, it is essential to establish approaches to reduce errors, to improve the security and storage of data, and to identify areas where there is a potential breach or compromise of the data that has been collected. The potential for errors in data collection is a continuous possibility; therefore, data collection must be as safe and secure as possible in order to prevent these conditions from taking place. A process known as Source Data Verification (SDV) is commonly used to test data samples in order to determine if they provide the desired outcomes and are appropriate for the study and its direction. In addition, supporting documentation is essential to the data management process in order to ensure that the collected data is supported by backup evidence. Furthermore, data management in an electronic format requires a comprehensive technology-based maintenance system that will protect data from being compromised by a third party, and may include the use of firewalls and other resources in order to maximize data protections. It is also necessary to address the possibility of erroneous data that is entered into electronic systems; therefore, it is important to identify methods to prevent this data as much as possible. Finally, all staff working on a clinical study must be able to effectively use electronic and other systems as necessary to ensure that the integrity of the study and the data that is collected is not unnecessarily compromised in any way at any point during the study. This will ensure that study staff have taken the necessary precautions to improve study outcomes.

Questions

1. What are the primary elements of Good Clinical Practice that researchers must consider when developing a study that involves human subjects? How should their IRB protocols address the key principles of GCP?
2. How do central laboratories and imaging services provide safe and secure data for clinical research studies? What are the most appropriate methods available to ensure that these tests are protected from unnecessary risks?