Clinical research managers are health care professionals responsible for overseeing and analyzing clinical trials. To do their jobs successfully, these individuals must possess strong organizational and communication skills as well as being adept at creating clinical trial protocols. If you want to advance in your nursing or health care career, consider earning an online clinical research management degree.
Clinical trial management systems (CTMSs) are software solutions that enable clinical research teams to track and manage all aspects of a clinical trial in one central location, streamlining processes and increasing efficiency while decreasing trial durations and operational costs. Unfortunately, many research organizations still rely on manual processes or different standalone systems for different functions which create redundant work and duplicate data that makes ensuring accurate, reliable, timely information difficult.
CTMS brings together all the different solutions required for running clinical trials under one umbrella, providing greater visibility across an entire research project while decreasing delays and errors with data entry. Furthermore, having all these services integrated reduces training staff on multiple systems as well as manual tracking of overlapped data sets.
Features of a CTMS typically include:
Clinical Trial Performance and Reporting – Provides reports/dashboards to communicate performance against targets. Protocol and Study Document Management – Allows review/management of essential study documents while tracking their approval status. Electronic Case Report Form (eCRF)/TMF Development – Enables creation of CRF/eTMF forms that track their status throughout a clinical trial.
CTMSs offer an efficient means of searching and accessing data quickly. They also can combine different datasets to provide more in-depth details, making the CTMS an invaluable asset when it comes to safety assessment, compliance monitoring and managing data flows between systems.
An additional key benefit of CTMSs is improved communication between clinical researchers and sponsors, which is essential for efficient collaboration, speeding up trials. A CTMS provides a central point for communication and collaboration that reduces trial duration significantly; its value becomes even more apparent when multiple sites participate; such a system makes for smooth operations in such cases.
A CTMS can also help facilitate efficient supplier management by streamlining interactions with vendors, helping select, evaluate and select suppliers as well as managing contracts and monitoring performance. In addition, it serves as a centralized repository of essential information regarding quality processes and audits so as to meet regulatory agency and other standards requirements.
Research Ethics Committees are responsible for assuring that studies involving human participants comply with local and international ethical guidelines, providing oversight over ongoing research while monitoring ongoing studies that do not meet ethical standards. They may approve, modify or stop studies that do not meet ethical requirements as well as monitoring ongoing studies to provide advice about ethical matters. Typically composed of experts in various scientific, medical, social and legal fields appointed for fixed terms by universities or health service organizations they usually follow established procedures when reviewing applications and formulating an opinion.
In England, Research Ethics Committees (RECs) are funded by the Health Research Authority and Devolved Administrations and ensure participants’ rights, safety, dignity and wellbeing are upheld during research conducted involving humans. In addition, RECs also manage HSE healthcare research’s ethics review service in England as a central resource of ethical considerations information for researchers and other stakeholders.
Recent surveys show that research ethics committees (RECs) are often perceived by academics and the general public as friends when their processes are navigable and transparent, yet seen as foes when their processes become restrictive or bureaucratic (Wiles et al. 2005; Hammersley 2009). Respondents noted how lack of understanding regarding research processes or its context could result in unnecessary restrictions being placed upon research activities.
A Research Ethics Committee should reach its decision after careful discussion and deliberation, taking into account research ethics principles and values. Furthermore, their decision must be grounded on scientific evaluation results such as identification and assessment of risks to participants as well as potential harm or discomfort to wider population; as well as reviewing documentation and following standard operating procedures to ensure its decision is valid without conflicts of interest or potential biases.
An ideal Research Ethics Committee (REC) would consist of both scientists and nonscientists in order to consider all aspects of research as well as its effects on individuals and society, gender equity, sociocultural diversity and hold open and fair discussions before reaching an unanimity decision.
The CTMS provides users with an efficient platform to oversee all stages of clinical trial processes from recruitment to reporting, by offering them access to a centralized and real-time operational database with full transparency and control, enabling all stakeholders to keep an eye on what’s going on at each step and take timely corrective actions when necessary. It allows users to map an entire clinical trial timeline, create an integrated subject calendar and track progress during its duration; plus features like screening forms, eConsultation, eSignatures and many other tools designed to streamline workflows and automate high volume SAE data reconciliation tasks.
A centralized and automated database helps teams increase team productivity while improving quality deliverables by decreasing time spent manually entering data, improving team productivity and quality final outputs. The software solution offers 21 CFR Part 11 compliance controls such as audit trails, archival storage and user account management; additionally it can easily conform to an organization’s practices and policies through field picklists, custom planning views and tracking views.
Cloud-based solution that unifies sponsors, CROs and research sites. Features include virtual portal, task management and dashboard applications – easy for users to use with minimal training required for setup.
Additionally, it offers customization features such as custom forms, eSignature, and other tools to assist researchers with streamlining their workflows. Furthermore, it provides a secure platform to store and share files as well as integrations with third-party apps – making this highly scalable and customizable system suitable for managing clinical trials processes from start to finish.
Pristima XD Core is an industry-leading preclinical software suite offering complete automation of lifecycle activities and support for pharmacology and drug safety research studies, animal care management and vivarium management. It connects preclinical teams to sponsors and CROs for improved collaboration, faster turnaround and simplified data submission processes; its robust feature set is suitable for small as well as large organizations alike.
Participating in a clinical trial is a personal decision with both potential benefits and risks. Before you make the commitment to join, researchers usually explain in great detail and answer any queries about it; the team should respect your rights while simultaneously protecting your safety.
Clinical trials can be found at hospitals, medical centers, clinics, doctors’ offices and other federally or industry-sponsored research sites. Participants for clinical trials are recruited through databases of patients or through newspapers/radio ads/flyers in places the patient might go (like schools). Furthermore, investigators may personally recruit participants. Depending on the criteria required for participation ( such as having a specific disease/version of gene), those agreeing to take part may need to meet certain requirements for inclusion such as having certain diseases/versions of genes for participation.
Empower your clinical research journey with Spinos, a leader in clinical research management. From overseeing trials to implementing cutting-edge CTMS and study management software, Spinos ensures efficiency and compliance. Elevate your career in healthcare with an online clinical research management degree. Join us for innovative solutions, shaping the future of clinical research.