DOCR has released the following new on-demand web-based training modules in the Duke LMS:
- Overview of Clinical Research at Duke – This module describes the drug or device development process, defines human subject research, explains why the entire clinical research community is interested in protecting human subjects, describes the patient’s experience, describes the study team and it’s oversight at Duke, describes the groups that enable and support clinical research at Duke, describes the progression of a Duke clinical study, and discusses protecting intellectual property.
- Reviewing the Literature and Determining the Research Question – This module describes reviewing the existing literature, and developing the research question and research hypothesis.
- Developing Grant Proposals – This module describes reviewing the existing literature, analyzing the audience, targeting your message, writing the proposal, and submitting the proposal.
- Study Design and Statistical Considerations – This module discusses population and sample size, the purpose and types of variables, subject assignment and controls, study types and treatment sequences, complex study types, reliability and validity, and collaboration with Duke experts.
- Developing and Writing the Protocol – This module describes who can assist you in developing and writing the protocol, the contents of the protocol elements, and tips for specific types of studies.
- Planning for Data Collection – This module describes how data can be shared, who is involved in the process, who owns the data, who can sign an agreement, why the data are collected, what data are needed, defining the data elements and creating the data dictionary, when data will be collected, how data will be collected, where data will be stored, documenting the data plan, building and testing the database, and defining the data collection process.
- Developing the Informed Consent Form – This module covers the key principles to protect human subjects, laws and guidelines, what is informed consent, when the informed consent process begins, the required elements of informed consent, the additional elements of informed consent, the one element that cannot be included, and the DUHS IRB informed consent form templates.
- The IRB and Submitting the Study to the IRB - This module describes the regulations that govern IRBs, who serves on the IRB, the IRB and Institutional review process at Duke, how much DUHS oversight is required for certain types of studies, how to submit the study using the eIRB system, when the IRB reviews the study, what the IRB reviews, and the possible outcomes of the IRB review.
You can find a link to each of the courses from the Available DOCR Training page on the DOCR website. From the Duke LMS home page, you can select the Category link in the Catalog Search section of the home screen, and then select DOCR. All available DOCR classes will be listed.