The protocol provides information on the background and rationale for a trial and outlines the study plan. The plan must be carefully designed to safeguard the health and safety of the participants, as well as answer the research question(s). All phases and sizes of studies should have a protocol that describes the essential elements of sound research practices – background/rationale, objectives, specific aims, study design, procedures, data collection/validity/quality, safety monitoring/management, a rationale for the chosen sample size choice, and a complete and adequately-detailed statistical analysis plan for each specific aim.
There are several resources at Penn to assist you with developing a protocol that includes all Penn required language in conjunction with other regulatory requirements. There are three protocol resources to support with this and they are Penn’s clinical trial protocol template, NIH observational protocol template and retrospective clinical research.
For industry sponsored studies, the protocol will be provided by the sponsor. For Penn Investigator initiated studies, the templates above should be used.
Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.
The main purpose of PV is to protect public health by maintaining accurate, up-to-date, and complete safety information on investigational and marketed interventional therapies.
A comprehensive resource on Pharmacovigilance Management [CDD1] can be located in the OCR Tools and Templates.