Project Planning & Implementation
Once you have decided to implement a project, there are many resources available for tasks that must occur before you collect any research data.
Prior to project planning and implementation, review our project development phase for the best way to start a research project. The project planning and implementation phase may have similar information as project development – both are essential to a successful project.
Phases of Project Planning & Implementation
- Receive Support in Finalizing Your Protocol and Statistical Analysis Plan
- Find resources for developing a protocol.
- Connect with a biostatistician for help with study design and management.
- Know Where to Obtain Approvals Needed to Begin Your Research
- Register your clinical research project in Velos.
- Submit your research project for IRB approval.
- Get IND/IDE Sponsor Investigator Support.
- Register your trial on clinicaltrials.gov.
- Obtain additional approvals needed to begin a study.
- Engage the Community in Developing Materials for Your Study
- Engage members of the DFW community in development of study materials.
- Prepare and validate documents in Spanish.
- Engage a study-specific stakeholder board in your study planning.
- Access Needed Equipment, Resources, and Scientific Expertise
- Access needed equipment and/or resources.
- Facilitate agreements for equipment, resource use, and collaborator engagement.
- Provide Required Training for Study Personnel
- Get required training for clinical research.
- Fulfill personnel and staffing needs.
- Finalize Your Study Data Capture Process(es) and Create Your Study Database
- Create your REDCap secure data capture project.
- Develop your database structure.
- Identify Strategies to Recruit Participants
Find participants for your clinical and translational research project.View Recruitment & Retention
Top Three Reasons that Studies are Delayed
Necessary approvals are not obtained.
Approvals take time – information needs to be gathered and prepared, and review times can vary. Knowing which approvals you need to conduct your research at the beginning of the process can save a lot of time and help ensure your study starts on time.
Recruitment methods are not adequate.
Obtaining accurate data and/or developing appropriate materials to recruit participants who are a good fit for your study is critical to achieving study goals and milestones.
Study staffing and training.
Delays occur when staff is not appropriately trained or when there are not appropriate backup plans in place for when staff is not available (e.g., vacation, illness).
Don’t know where to start?
Schedule a consultation with a research concierge via CTSAProgram@utsouthwestern.edu.