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Compliance In Focus
Posted by Heather S. Friar on Wed, Sep 4, 2019

Data Integrity is Important for the Success of Clinical Trials



Data Integrity III-1

Data integrity is a fundamental requirement of medical research and laboratory experimentation. All studies should be conducted according to the protocol guidelines and documented accurately and completely even if the data disproves or challenges the posted hypothesis. As researchers, it is our responsibility to make sure the study is conducted ethically and honestly. The results of the study are used to justify the effectiveness of a procedure, medical device or pharmaceutical. The goal is to improve the overall health and welfare of humans. Lack of data integrity could prove to be a disaster as something originally thought to be safe could cause unexpected pain or death.

What is data integrity? Data integrity is defined by the Segen’s Medical Dictionary as “A dimension of data contributing to trustworthiness and pertaining to the systems and processes for data capture, correction, maintenance, transmission and retention. In clinical research, the FDA requires trustworthiness of data relied on to determine safety and efficacy of therapeutic interventions, and establishes guidance and regulations concerning practices and system requirements needed to promote an acceptable level of data integrity.” Peer review of the data and the ability of researchers to replicate one another’s results identify erroneous conclusions and preserve the integrity of the research.

Data integrity is the responsibility of everyone associated with the study from data collection through reporting. The study results should be accurate, traceable and reproducible if the study were to be repeated. Human mistakes and errors will happen. These errors do not signify a compromise to integrity. Only if the error results in an intended deception, will the integrity be considered compromised. Errors need to be addressed immediately and well documented. Steps, such as a corrective and preventative action plan (CAPA); need to be put in place to prevent the error from occurring again.

What can happen when data integrity is compromised? The Principal Investigator (PI) can be sent to prison if it was found to be intended deception. By law, the maximum sentence could be up to five years. In addition, there can be monetary fines and mandatory re-payment of grant and/or private funding awards. The PI may be debarred from ever participating in clinical research. Not only is the reputation and credibility of the PI tarnished, but depending on the severity of misconduct; global medical and manufacturing companies could lose billions of dollars in potential product sales and revenues. These losses result in company closures and increased unemployment rates. Most importantly, there is disqualification of the public’s trust. In order for medical advancement to continue, clinical trials are necessary. In order for clinical trials to continue, the support and participation of the public is essential.

Trust is a belief that we can rely on an individual or organization to perform competently and responsibly. Trust is extremely vulnerable. We cannot believe that we are entitled to be trusted. As people and researchers, we must earn trust.

Lastly, a clinical trial should be conducted under the guidelines of Good Clinical Practice (GCP). The purpose of GCP is to ensure that the studies are scientifically and ethically sound by protecting the rights of human subjects and validating the study data. As researchers, it is our responsibility to make sure the study is conducted honestly and according to protocol. Our goal as clinical researchers is to improve the overall health and welfare of humans by securing the integrity of clinical trials through valid data collection, protecting the rights and safety of the participants all while maintaining compliance with the FAIR Shake (Federal Regulations, Agreement with the Investigator, Investigation Plan and Requirements of the IRB).

What are some of the everyday practices you do to ensure the integrity of your data is not compromised? Why is trust an important element for the success of clinical research?


photo credit: NZ Landcare Trust #CitSciNZ2018 Using TrapNZ Trapping Records to Monitor Pest Control Activity via photopin (license)

Topics: Good Clinical Practice, The FAIR Shake, Data Integrity


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