GCP and Audit Preparedness

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2023 Agenda

Saturday, September 30, 2023 at 3:25 to 4:10                                                                                    Track: GCP and Audit Preparedness

Proper Documentation of a Clinical Trial: What are all these forms and how do I complete them?

From Case Report Forms to Adverse Event, Deviation, Screening-Enrollment, Delegation of Authority and IP Accountability Logs, there is A LOT of information to be recorded when documenting a clinical trial. Both new and experienced study team members often have many questions on ‘Best Research Practice’ when it comes to filling out essential forms. When the regulations are silent, IRBs, institutions, sponsors, CROs, and investigators are free to develop their own procedures and practices as long as applicable regulatory requirements are met. However, certain elements should be taken into consideration when determining how to record data with integrity (reliable, accurate, complete, consistent, trustworthy, in context). This talk will present background information on WHY the forms are needed and guidance on HOW best to complete them to comply with regulations.“ 113
Presenter: Laura Adkins, MAP, CCRP, CCRA, CRS, AdvCRS, Director, UAMS Office of Research Regulatory Affairs

Saturday, September 30, 2023 at 4:15 to 5:00                                                                                         Track: GCP and Audit Preparedness

Informed Consent in Clinical Research: Getting it Right!

Ms. McAvoy will introduce Informed Consent in Clinical Research starting with a brief historical overview of why informed consent is important using examples (e.g., Nuremberg Trials). The speaker will describe what the consenting process is, how to document it correctly, special considerations, plus common errors and audit findings related to the informed consent process. Research Ethics Board requirements in the form of templates and checklists will be covered, plus additional topics such as assent, alterations/waivers to consent, consent for secondary use of identifiable information, and how email plays into the informed consent process. Finally, Ms. McAvoy will provide some tips for writing patient-centered informed consent forms. 115
Presenter: Elizabeth McAvoy, MA, CCRP, Associate Director, Kingston General Health Research Institute