Clinical Research Compliance: Multiple Challenges, One Solution


In the last couple of years, there has been a steep increase in the number of clinical trials and researches that have been carried out on a global scale. This has been fueled by a number of factors such as increased funding, advanced medical training, improved technological infrastructure, and a unified global outlook towards health and disease.

As this is happening, researchers worldwide are having to deal with seemingly insurmountable regulatory challenges that may limit or deter the successful completion of clinical research. Apart from the financial and logistical hurdles, researchers need to ensure that they do not breach the privacy and confidentiality of the research participants. This has created a dire need for data management systems to support the process and help researchers meet regulatory requirements seamlessly.

Previously, electronic health records (EHRs) have played a major role in the management of clinical research data. However, with the increasing regulations in the industry, more advanced systems are necessary to increase accuracy and efficiency while reducing redundancy. Researchers are beginning to discover that it is more important to have compliant and reliable data than it is to have “complete” data.

Interoperability is another major concern that comes with collecting clinical research data. It implies that data collected can be freely shared across different platforms. At the end of the day, standardization and quality are a priority. In the same vein, the clinical researchers must ensure confidentiality to protect the study participants and to remain in compliance with the law.

Different agencies are tasked with the responsibility of overseeing clinical research activities in different countries. For the European Union (EU), the General Data Protection Regulation (GDPR) that was enforced on 25 May 2018 has regulatory oversight in this area. It sets obligations and sanctions to ensure compliance. This law is considered to have a “dual footing.” It not only facilitates the free flow of information but also ensures that personal data is safeguarded. This, in brief, is the right to privacy and protection of personal data. Each clinical research organization must ensure accountability in adhering to the GDPR and must prove compliance beyond a reasonable doubt. The GDPR applies to all organizations that are handling the personal data of the citizens of the EU, irrespective of the geographical location of the organization.

The Department of Health and Human Services (HHS) has two agencies that regulate clinical research: Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the US.

Additionally, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) is involved in regulating clinical research. The Medicines and Healthcare Products Regulatory Agency (MHRA) oversees clinical trial approvals and inspections and also grants permission for clinical trials in accordance with the e MHCTR2006 in the UK.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) ensures that standards of privacy and compliance are upheld.

Clinical research has been in the spotlight as the public has become more aware of their rights and privileges. Researchers must do everything possible to ensure that they remain in compliance with all the stipulated laws and regulations that apply.

In the US, the Food and Drug Administration (FDA) oversees clinical research. The rights and protections of human participants are enshrined in the Common Rule. Other agencies that are involved include the Center for Drug Evaluation and Research (CDER), the Office of Good Clinical Practice (OGCP), and the Center for Biologics Evaluation and Research (CBER) all of which play a crucial role in regulating clinical research.

In Canada, Health Canada Research Ethics Board (REB) plays a similar role to the FDA and HHS in overseeing clinical research.

All these agencies have a common goal which is to ensure that the dignity and rights of human research participants are maintained by ensuring their safety and data privacy.

Several issues can jeopardize the integrity of the research as well as the reputation of researchers. Failure to obtain informed consent is a crucial issue with serious repercussions. Informed consent means more than just getting a research participant to sign on the dotted line. The investigator needs to educate the participant on every aspect before asking them to sign the consent form. This information should be retained in the participant’s medical record. The consent can be updated with time and this should be captured in the records as well. The research participants should be given the liberty to withdraw their consent anytime.

Other ethical issues include failure to obtain IRB approvals and adhere to other set protocols.

Keeping up with the regulatory guidelines, audit trails, privacy and consent requirements, ethical and legal issues can be an uphill task. For researchers, this can be a difficult terrain to navigate.

Unfortunately, non-compliance is bound to attract hefty penalties.

What is the Solution?

Considering all the non-compliance issues that are likely to crop up, the importance of an appropriate data management system cannot be overemphasized.

A cloud-based Clinical Research Laboratory Management Software can be the ultimate compliance solution for clinical research.

To begin with, a Clinical Research LIMS can help in managing subject information such as demographics, clinical history, and informed consent. It can also help in managing SOPs, keeping records of compliance, and highlighting deviations that need to be addressed. It can also help in automating workflows and providing remote access to research documents and data. It can facilitate clear audit trails and allow real-time digital monitoring and querying across different time zones.

With the globalization of health and clinical research coupled with increased public awareness, the issue of compliance cannot be taken lightly. A digital solution, such as a cloud-based clinical research laboratory management software, is needed to protect all stakeholders while ensuring the best results from clinical research.