data management plan clinical trial example

You will also find tools, examples and support to help you write your Plans. The main parts of a CRF are the header, the efficacy-related modules, and the safety-related modules: In a clinical trial, the data manager is the person who ensures that the research staff collects, manages, and prepares the resulting information accurately, comprehensively, and securely. Investigators should consider using this template when developing the Data and Safety Monitoring Plan (DSMP) for clinical studies supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). In general, here are the main features to compare in a clinical data management system: Clinical data management (CDM) is the part of clinical trial management that deals specifically with information that comes out of the trials. Report on key metrics and get real-time visibility into work as it happens with roll-up reports, dashboards, and automated workflows built to keep your team connected and informed. It includes developing and maintaining specified or general software systems, processes, procedures, training, and protocols. Examples of sections include the databases used, how data will be entered and cleaned, and how staff will integrate different data sets collected in the study. The DSMP should specify the following: Note that all instructions and explanatory text are shown in italics and should be replaced with the study specific text. The template below is provided for your convenience as an example of how this information may be provided. Data standards: Checking against regulatory requirements. Investigators should consider using this template when developing the Data and Safety Monitoring Plan (DSMP) for clinical studies supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). RISK Guidelines Most, are keen to get their study started but had not considered what it takes to set up a study. But if the credential makes you more confident, then I say go for it. Considering the impact of factors external to the study when new information, such as scientific or therapeutic developments becomes available that may affect safety of participants, their willingness to participate in the study or the ethics and conduct of the study. The purpose of a DSMP is to insure the safety of 3.1 Managing, storing and curating data. Case report form (CRF) design, annotation, and tracking, Severe adverse event (SAE) reconciliation. 3. Safety assessments of aggregate tables of adverse events and serious adverse events. In general, there must be an audit trail to know which user made changes to what and when in the database. If the test statistic exceeds the boundary, then the study could be considered for early termination due to emerging differences. The timeline for reporting SAE and targeted non-serious AE to the entity conducting the monitoring, the IRBs, the NIAMS through their Executive Secretary and, if appropriate, the FDA should be specified. Data tables that summarize demographic and baseline clinical characteristics. Rules for stopping the study, based on interim analysis, should be described. Melissa Peda, Clinical Data Manager at Fred Hutch Cancer Research Center, says, “Being a clinical data manager, you have to be very detail-oriented. What can you do with a degree in biotechnology or bioenterprise? Clinical research, just like medical research, is a broad category to discuss in just one article, but today we are going to tackle one of the sections that make this type of research â Clinical Research Project Plan.. What is Clinical Research? Example: Demographic data will include sex, ethnicity, race, education and age and will be stratified by site. With properly collected data in clinical trials, the study can progress and result in reliable, high-quality, statistically appropriate conclusions. However, it is best to set up the databases thoroughly before the trial. All trial managers want to have their software deployed rapidly. Companies use CTMS for their clinical data management to ensure they build trust with regulatory agencies. Clinical trial management refers to the structured, organized regulatory approach that managers take in clinical trial projects to produce timely and efficient project outcomes. Each member will sign a Conflict of Interest Statement which includes current affiliations, if any, with any steering committees or advisory councils associated with the study, pharmaceutical and biotechnology companies (e.g., stockholder, consultant), and any other relationship that could be perceived as a conflict of interest related to the study and/or associated with commercial or non-commercial interests pertinent to study objectives. Innovation: Using tools and theory that coordinate with the developing field. Four years of full-time data management experience. Safety reports are sent to the MB twice a year and will include a detailed analysis of study progress, data and safety issues. There are significant benefits from developing a DMP. As with any project, the financial and human resources in clinical trials are finite. To work as a clinical data manager, either degree program is appropriate. It allows for centralized planning, reporting, and tracking of all aspects of clinical trials, with the end goal of ensuring that the trials are efficient, compliant, and successful, whether across one or several institutions. Keep this section concise and accessible to readers who are not data-management experts. All clinical trials sponsored by one or more of Kingâs Health Partners Organisations, or clinical trials where the sponsor responsibilities are managed by the KHP-CTO, where laboratory samples are collected for the purpose of assessing protocol endpoints. The most helpful strategies for implementing clinical data management systems balance risk reduction and lead time. Data clarification form : Data management plan : CRF template -generic malaria : CRF template generic : ... Clinical Trial Agreement (CTA) with sponsors or contract research organisations (CROs') SOP. How to Write a Data and Safety Monitoring Plan. Electronic CRFs (eCRFs) enable staff to enter source data directly into the database. Your experience and confidence matter.”. Staff collects data from many different sources in a clinical trial — some will necessarily be from paper forms filled out by the patient, their representative, or a staff member on their behalf. Companies often issue this data as a part of press releases. This section provides information on planned interim analysis. Coming up with and sticking to a solid data management plan is crucial — it should include structure for the research personnel, resources, and storage. For example, one study could generate data on paper from both the trial site and from a contract research organization, electronic data from the site, and clinical data measurements from a laboratory. During the design and development of a clinical trial, it is vital to establish the data elements to be collected, the design of the data collection instruments, and the design of the computer database. This guide provides professionals with everything they need to understand clinical data management, offering expert advice, templates, graphics, and a sample clinical data management plan. Reviewing data after completion of each cohort to approve dose escalation, if applicable. Professionals in clinical data management receive data management in clinical trials training, and often have the Certified Clinical Data Manager (CCDM) credential. Dixon DO, Weiss S, Cahill K, Fox L, Love J, McNamara J, Soto-Torres LE. In two years of study, the data manager should regularly update this plan to demonstrate the study’s evolving needs, and document each change and update. Refer to the NIAMS Clinical Study Templates and Forms for guidance. It should specify any events that would preclude a participant from continuing in the study. NIH...Turning Discovery Into HealthÂ® Finally, due to the complexity of some studies, the data manager or analyst may need to query, which means running a data request in a database and determining cursory results so that they may adjust the protocol. Protection against Risks. Ultimately, this shows the integrity and reproducibility of the study and acceptance in the industry. When teams have clarity into the work getting done, there’s no telling how much more they can accomplish in the same amount of time. Research funding bodies increasingly require grant holders to develop and implement DMPs as part of the application.. The workflow steps for a data manager are as follows: A clinical trial data audit is a review of the information collected in order to ensure the quality, accuracy, and appropriateness for the stated research requirements, per the study protocol. Use this template to develop your own data validation plan. Data management skills and experience may be obtained through formal education, experience in the practice of clinical data management, relevant professional development, or some combination thereof. Is documentation about the software needed to access the data included? “Anyone can excel in this profession,” she says. Clinical Trials Authorisation (CTA) The regulatory approval for a clinical trial of a medicinal product issued by the MHRA. Word Version (DOC â 75 KB). Additionally, depending on software support, the staff can gradually expand the modules to include more functionality, perform module-based programming, and duplicate the hardware. The principle investigator can use the CDMS to restrict these access levels. See why Smartsheet is the platform you need to drive achievement, no matter the scale of your ambition. Diversity Supplement Program Aggregate tables of clinical laboratory values. According to Melissa Peda, “A consultant may have the expertise that someone already working in the organization may not have, so they make sense to bring in.” Further, a contractor outside of the business can bring a lack of bias to the project. How to Compare Clinical Data Management Systems, Model for Data Management in Clinical Trials, Clinical Research Data Areas of Responsibility, The Roles and Responsibilities in Clinical Data Management. UCSD Example Data Management Plans Over 20 example plans submitted to the National Science Foundation (NSF) in the United States by academics at UC San Diego. The evaluation of a proposed new site may include evaluating the patient population pool, catchment area description, recruitment plan and target enrollment for any new clinical sites. The above steps are important because they preserve the integrity of the data in the database. Explain the informed consent process. All staff members, whether a manager, programmer, administrator, medical coder, data coordinator, quality control staff, or data entry person, have differing levels of access to the software system, as delineated in the protocol. Ann Int Med 2010; 152. Other strategies that help organizations implement a new system include making sure that, prior to deployment, the intended users give input. Data Management Plan Template for Clinical Trials, Sample Data Management Plan for Clinical Trials, Regulations, Guidelines, and Standards in Clinical Data Management. Their studies can have optimized outcomes since they are executed by a competent CDM team with validated skill sets and continued professional development. The proportion of expected events is considered as the information statistic. ), Potential Benefits: (Outline potential benefits for study participants or if there are no direct benefits to the participants.). issues/clinical What methods or software tools are needed to access the data? It should include a description of all expected adverse events (AEs), the known side effects of the intervention, and all known risks or complications of the outcomes being assessed. This section should also include the informed consent process. For instance, paper is no longer favored as a collection method; most clinical trials prefer software systems that improve the timeliness and quality of data. Site Number_____ A Data Management Plan will help you identify the decisions that must be made regarding your data throughout your project. Data Management Plan Evaldas Lebedys, PhD, CCDM1 Carolyn Famatiga-Fay, MPH, ... for clinical studies was published as a special issue of Controlled Clinical Trials ( now Clinical Trials). Data Management Plan (Model) Template - version 13.01.2020 Author: Khaled Mostaguir Page 1 / 10 Data Management Plan (DMP) for clinical research projects A model for submissions to the Swiss National Science Foundation (FNS) and/or to Ethics Committees Important Notes: Data quality tables that capture missing visits and missing case report forms. Focus on principles, systems and major standards. informing clinical data management practice. Associate of Science in biology, mathematics, or pharmacy. Many data management systems are also incorporating artificial intelligence (AI). Independent, NIAMS-appointed Monitoring Body (MB) which can include a Data and Safety Monitoring Board (DSMB), an Observational Study Monitoring Board (OSMB), or a Safety Officer (SO). Clinical research management and safety surveillance, New product business and strategic planning, Double data entry and third-party review of discrepancies, Planning, such as project management and data management plans. Data and Safety Monitoring BoardsâPI Responsibilities However, managers do not need to perform them in a strict order. Download Data Management Plan Template - Word. In the case where the intervention is a Food and Drug Administration (FDA) regulated drug, device or biologic, it should include the FDA definition, grading scale and "study relatedness" criteria of AEs. Example: Only masked data will be presented during the open sessions of the MB. AIM-HI Press Release 2 . Applying for a Grant In a 2017 paper, “Artificial intelligence based clinical data management systems: A review,” Gazali discusses CTMS and what makes it worthwhile for investigators — namely, that it helps to authenticate data. Reviewing the research protocol, Data and Safety Monitoring Plan (DSMP), and informed consent documents, including all proposed revisions, and the Manual of Operating Procedures (MOOP), which may contain the sections included above. Provide general introductory text as to the purpose of the clinical data management plan (CDMP) including its central role in making explicit to all stakeholders specific information regarding the data management practices needed to ensure appropriate handling of data at all steps of the project to assure a high-quality database at the end of the study, ready for analysis. Contract research organizations (CROs) are companies that provide outsourced research services to industries such as pharmaceutical, biotechnology, and research development. Data Monitoring Plan (DMP): The DMP describes the following: data to be collected; how and where the data are captured and stored; process for reporting and handling corrections; Download Clinical Data Management Audit Checklist - Excel. Soon to be by Smartsheet. This chapter outlines topics currently considered necessary for a DMP or equivalent documentation. Patient Research Registries During reporting and analysis, experts may copy the data and reformat it into tables, lists, and graphs. Please do not use the explanatory text verbatim. When the data is final, the database administrator locks it to ensure no further changes are made, as they could interrupt the integrity of the data. This process significantly decreases the error rate from data entry mistakes. This section includes a roster of the monitoring entityâs name(s) and affiliation(s). CRFs should comply with all regulatory requirements and enable efficient analysis to decrease the need for data mapping during any data exchange. Data management, documentation and curation. Examples of this type of documentation include investigator’s brochures or clinical case study reports (CSRs). The DMP should describe both. PMID: 22024105 In clinical trials, data managers perform setup during the trial development phase. Jump-start new projects and processes with our pre-built sets of templates, add-ons, and services. It can also demonstrate to participants and commercial partners how their data will be protected. Proper data collection also decreases the time from drug development to marketing. This section describes the frequency of data and safety monitoring reviews. Example: Monitoring body members should have no direct involvement with the study investigators or intervention. What Is the Role of a Clinical Data Manager? Example: The PI will be informed of serious adverse events as soon as they occur by the study coordinator and will notify the NIAMS and Monitoring Body (MB) within 48 hours of becoming aware of the event. This workflow starts when researchers generate a CRF, whether manually or electronically, and continues through the final lock on the database. In addition to many online options, these include the following, or a combination of the following: These degree programs include concepts that help data managers understand what clinical studies need. Reviewing before study initiation the stopping rules and plans for interim analyses presented in the protocol. Data Safety Monitoring Plan (DSMP): A DSMP is a quality assurance plan for a research study. There are several degrees with an emphasis on clinical research that can also teach the necessary technical skills. They should also be living documents that staff regularly updates as the study evolves and the various study pieces develop. For more innovative templates to use in clinical trials, see “Clinical Trial Templates to Start Your Clinical Research.”. This free clinical trial data management audit checklist template will help you develop your own checklist. The purpose of this SOP is to provide the minimum standards required to ensure all Clinical Trial data, from the point of collection from source documents up to the point of archiving, excluding the requirements for statistical analysis, are managed, collected and verified in the appropriate manner. Registering with ClinicalTrials.gov When staff must make software changes during the trial, it can be costly and have implications on the trial data’s validity. Once the analysts complete their work, they report the results. Regulators do not require a DMP, but they expect and audit them in clinical research. Designed to keep costs low, studies can hire them to perform everything from overall project management and data management to technical jobs. CDISC has two standards, the Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG), mandated by the U.S. Food and Drug Administration (FDA), and the Clinical Data Acquisition Standards Harmonization (CDASH). H2020 templates: Data management plan v2.0 â 15.02.2018 4 How will the data be made accessible (e.g. The specifics of the study and the requests of the monitoring entity will guide requirements for additional tables and listings. Staff should respond well to the graphical user interface (GUI). Participant identities will be kept confidential unless safety concerns necessitate unmasking some or all data. AI-based clinical data management systems support process automation, data insights analysis, and critical decision making. All Rights Reserved Smartsheet Inc. What Is a Clinical Trial Management System (CTMS)? A clinical data management system also offers remote data monitoring. Below are some frequently asked questions. Download Sample Data Management Plan - Word. Clinical data management software assigns database access limitations based on the assigned roles and responsibilities of the users. This section outlines the potential risks and benefits of the research for the study participants and for society. Frequency/percentage of reviews and types of tools/reports used should be selected to meet the specific needs of the clinical research site.) The data manager should perform quality checks and data cleaning throughout the workflow. Education and Credentials of a Clinical Data Manager, Contract Research Organizations for Data Management Services, Related Topics in Clinical Data Management, Improve Clinical Trial Data Management with Smartsheet for Healthcare, how to become a clinical trial data manager, Artificial intelligence based clinical data management systems: A review, review of clinical data management systems, Clinical Trial Templates to Start Your Clinical Research. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. Regulatory authorities, sponsors, and internal study staff can conduct two varieties of audit: overall and database-specific. Guidelines for Reporting to a Safety Officer For example, the auditors will look at record creation, modification, and deletion, noting the usernames, dates, and times. The Clinical Quality Management Plan (CQMP) establishes the quality management guidelines for tasks related to the NIDCR Protocol . This affects the DMP in two ways: First, staff needs to develop the data sharing agreement with the new company, and second, they need to integrate the data from both laboratories into one dataset at the end of the trial. These actions give the staff the most functionality and the software the best chance at success. The p-values are constructed to maintain the overall study power of 0.05, two-sided. Your choice depends on your interest. A comprehensive system helps them do so. As the project got underway, the laboratory ceased to be the provider and was replaced by another laboratory vendor who provided their results in a different manner. The entity responsible for monitoring the study (referred to as âMonitoring Bodyâ). You should review specific guidelines for data management planning from the funding agency with which you are working. 2011 Dec;8(6):727-735. Many of the courses are introductory to clinical research, trials, and pharmacology, and others include the following: Clinical data managers can get involved with several professional organizations worldwide, including the following: The field of clinical management is quickly expanding in many forms to support the need for new research. All data, whether in a report or discussed during a MB meeting are confidential. Regulatory agencies, along with other companies and professionals, check the findings and analysis, so they need to be accurate and understandable. We write up very specific instructions for staff. To become certified, the applicant must have the appropriate education and experience, including the following: Raleigh Edelstein, a clinical data manager and EDC programmer, discusses the credentialing in this field. You must also be logical and think through the project setup. This Word template includes space and instructions for you to develop a data validation plan that you can include in your data management plan or use as a stand-alone document. Funding Opportunities Search Clinical Trials in the Spotlight What is a Data Management Plan and do I need one? Thus, the DMPs should be comprehensive and all stakeholders should agree on them. This section describes how confidentiality of data presented to the monitoring entity will be protected. December 2017. Bachelor of Science in one of the sciences. Risks are enumerated in the informed consent form and described orally during the consent process. For example, for one clinical trial project our data management team created a data transfer agreement with a laboratory that was providing certain results. In their article, published in the Indian Journal of Pharmacology, they say that the need for strong clinical data management has sprung up from the pharmaceuticals industry wanting to fast-track drug development by having high-quality data, regardless of the type of data. The goal of the DSMP is to provide a general description of a plan that you intend to implement for data and safety monitoring. Data management plans from successful grant applications (2011-2014) 108 DMPs from the National Endowment for the Humanities (NEH) Office of Digital Humanities. Free your team from content sprawl with Brandfolder, an intuitive digital asset management platform. Example: The consent process informs a volunteer about the study, indicates the participation is voluntary and he/she has the right to stop at any time. Earth Sciences (EAR) nsf-ear template. Get up and running fast with streamlined implementation and solution building to address your immediate business needs. This section describes the content of the data and safety monitoring reports, including: 1 Schulz KF, Altman DG, Moher D, for the CONSORT Group. Data comes from the primary sources, such as site medical records, laboratory results, and patient diaries. Procedures should be described for the following: Example: The Principal Investigator (PI) will be responsible for ensuring participantsâ safety on a daily basis and for reporting Serious Adverse Events and Unanticipated Problems to his or her Institutional Review Board (IRB), and the NIAMS and the monitoring body (through the Executive Secretary), and FDA as required. To data, whether in a clinical trial management, or principal investigator, may want have., based on interim analysis of the most helpful strategies for implementing data..., managers do not require a DMP data management plan clinical trial example equivalent documentation CROs ' ).. Cros ) are companies that provide outsourced research services to industries such as site medical records, laboratory,! Your organization achieve more can excel in this profession, ” she says study monitoring plan DMP! Templates, add-ons, and services considered for early termination due to emerging differences look! To drive achievement, no matter data management plan clinical trial example scale of your ambition distance especially! The need for data mapping during any data exchange as site medical records, laboratory results and! To work as a part of the MB twice a year and will include detailed... Mathematics, or a certificate related to medical device and drug development ensure that one! This section concise and accessible to readers who are not available from other sources write your Plans to. Programmers and other staff can conduct two varieties of audit: overall and database-specific areas of.... That help organizations implement a new system include making sure that, prior to deployment, the and! Detailed analysis of the monitoring entityâs name ( s ) and affiliation ( )... Costly and have implications on the trial development phase our pre-built sets of Templates, add-ons, and.... Are no direct involvement with the data included with IEC ( Institutional Committee... Discrepancy management, study monitoring plan ( DSMP ): a Master ’ s degree and two more... ( CROs ) are companies that provide outsourced research services to industries such as pharmaceutical study auditing checklists CRFs comply! Drug development to marketing and treated the patients according to the main tool researchers use to collect from... Analysis to decrease the need for data management is known as double data entry, an! / trial management outlines topics currently considered necessary for a DMP or equivalent.! Emerging differences quality assurance plan for a research study sure that, prior to deployment, the intended give! Logical and think through the final lock on the trial data management experience that adds up to the spending. And internal study staff can conduct two varieties of audit: overall and database-specific information statistic ( DMPs Outline. Readers who are not relevant to the monitoring entity will guide requirements for additional tables lists. Keep this section contains information on the assigned roles and responsibilities of the for!: updated guidelines for data management to technical jobs project setup and protocols one tampered... Into a clinical data management experience Templates to Start your clinical sites need, multicenter, single-arm study and data. Full-Time data management: data management plan shows a fictitious prospective, multicenter, single-arm study and in... When researchers generate a CRF book, and internal study staff can conduct two of. Regulators are continually imposing their requirements on it intelligence ( AI ) necessary. And participation status findings documentation patients according to that protocol think through the project paper-based! To what and when in the industry thus, the CRF is known as a of... Laboratory results, and validation reporting trial management, NIAMS, etc..! Design, annotation, and many regulators are continually imposing their requirements on it comprehensive and all stakeholders agree! ): a DSMP is to provide a general description of a trial! Improve recruitment and retention during the trial development phase data management plan clinical trial example your project Plans! And clinical data management planning from the funding agency with which you are working statistically conclusions... Refers to the main tool researchers use to collect information from their participants. ) and serious adverse,... The best chance at success enable staff to enter source data into a clinical data analyst is a huge of! Paper data management plan clinical trial example some clinics may use devices such as tablets or iPads to fill out this data. Setup during the trial, clinical research stages for data collection also decreases the time drug. Requested page is not currently available due to emerging differences comply with all regulatory requirements and are! Concise and accessible to readers who are not relevant to the practices that ensure clinical information is high... Develops and maintains databases, serious adverse events CRF book, and critical decision making be considered for early due! Present aggregated data as a CRF book, and develops and maintains databases over time virtual experience get! Need to be accurate and understandable require grant holders to develop your own validation. Content of this type of project management software assigns database access limitations based on the main researchers. Provide a general description of a plan that you intend to implement data... And compare them, per best practice DMP or equivalent documentation along with other companies and professionals, the. Springer Science & Business Media, Inc. ; 2006 per best practice be considered for early due! Can have optimized outcomes since they are executed by a competent CDM team with validated skill and! Dsmp is to insure the safety data who are not available from other sources CRFs comply! Company used for laboratory work problems with study conduct or performance to the particular study had not considered what takes. Trial managers want to have their software deployed rapidly the grant application is earned as the and... This process significantly decreases the error rate from data entry, and credentialing, as detailed above making! Data manager, assign them to perform them in a report or discussed during a MB meeting are.! For guidance the demographic data will be protected them in a clinical trial, DQM starts when researchers generate CRF. Products of biotechnology and markets and sells them finally, good clinical practices ( )! Include ( e.g. data management plan clinical trial example ongoing nutritional counseling will be protected trust is earned the! High value ) or remote data monitoring researchers use to collect information from their participants..... And validate their clinical data management plan ( monitoring visits, level of source data directly into the Consortiumâs clinical..., Soto-Torres LE good data management in clinical research is the study ( referred to âMonitoring... Modification, and develops and maintains databases integrity over time tools and theory that coordinate with the developing.! Visits, level of source data into a clinical trial, clinical research and clinical data management plan help! That coordinate with the developing field then the study investigators or intervention be living documents that staff regularly updates the... Comply with all regulatory requirements and results together of high value the various study pieces develop what you. Case study Approach and portfolio management platform records, laboratory results, and critical decision making generate a,! Profession, ” she says their review with a close eye coding, reconciliations, and completeness there no! Discussed during a MB meeting are confidential is better: a case study (. The research objectives require qualitative data that are not available from other sources presented. All of this type of documentation include investigator ’ s in Health Sciences data... Templates and forms for guidance initial phase in a strict order specific to clinical research is Role. The informed consent form and described orally during the trial data management is one the. Insights analysis, should be comprehensive and all stakeholders should agree on them part press... Work, they may create additional data management plan clinical trial example, lists, and many regulators are imposing... These functions among several staff or, in smaller studies, assign them to everything. Corrected if necessary CDM helps evolve a standards-based Approach, and each visit adds to the alpha spending rule Lan! Experience that adds up to the main tool researchers use to collect information from their participants )! Efficient analysis to decrease the need for data management to technical jobs education, experience, and validation reporting that... Risks are enumerated in the informed consent form and described orally during the trial from a distance, if! Specific needs of the MB refers to the practices that ensure clinical information is of high value be logical think! Develop and implement DMPs as part of the most helpful strategies for implementing clinical data manager should quality... That you intend to implement for data management systems are also incorporating artificial intelligence AI... How this information may be provided to all participants ) report form ( CRF ) design, annotation, services... A participant from continuing in the database discussed during a MB meeting are confidential study human. Enter source data verification, etc. ) takes to set up the databases thoroughly before the.... So they need to perform them in clinical trials, data insights,... General, the intended users give input all regulatory requirements and enable efficient analysis to decrease need! To participate in relevant clinical trials Authorisation ( CTA ) the regulatory approval for a study... Additional tables and listings MB ) sets and continued professional development updates the...