Clinical Trials Toolkit
Advanced Modules
Advanced Module Topics are available below for investigators who want a more in depth understanding of the research concepts. Topics are presented through videos and online resources similar to the basic modules. Be sure to check out the basic modules before proceeding to the advanced topics.
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ALCOA C and Documentation
The seminar describes the importance of documentation for a research study and reviews the concept of ALCOA C (Attributable, Legible, Contemporaneous, Accurate and Complete).
Common Rule Revision
In 2017 , the Common Rule was revised for the first time since its publication in 1991 to better protect study participants. In OHRP’s Thinking on Key Revisions to the Common Rule, the OHRP director reviews the common rule revisions and its impact on research.
Data Management
Data Management is an important part of research planning. The seminar Data Management & Case Report Form Development in Clinical Trials provides information on types of data source documents and case report forms.
For help in preparing your data management plan use the Data Management Plan Tool for free templates and help in the creation of the plan for your study.
Investigational New Drug Application
An Investigational New Drug (IND) application is a request to the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. The Regulatory and Administrative Components of an IND Application provides a quick overview of IND application, while the Demystifying the Investigational New Drug (IND) Application for Drugs and Biologics video goes into more depth.
Investigator Forms 1571/1572
Forms play a key role in FDA research including INDs and other sponsored research. The video Investigational New Drug Application (IND) Forms: Updates and Best Practices reviews the IND application forms in depth.
More information can be found:
How to Complete Form FDA 1571 and Form FDA 1572
Monitoring Plans
Monitoring plans are an essential part of investigator initiated clinical trials. Developing Monitoring Plans for Investigator-Initiated Clinical Trials reviews the expectations of the sponsor in monitoring a clinical trial, types of monitoring that can be used and the essential elements of the monitoring plan.
Safety Reporting
The FAERS seminar is a short video reviewing the database the FDA uses to house AE and medication errors. Investigational New Drug Safety Reporting Requirements explores the key considerations in identifying and reporting safety issues in clinical trials.
Statistics
Statistical Considerations: Phase 1 & 2 Clinical Trials includes an overview of clinical trial phases, statistical endpoints, and other data considerations. IPPCR 2019 Issues in Randomization is part of the NIH randomization series.
Study Design
Design of Clinical Trials Outcome Measurements & DSMB is a primer on study design randomization, hypothesis testing, and the role of data safety monitoring boards.
A New Path Forward for Using Decentralized Clinical Trials explores study design for the expanding field of remote studies.
Pediatric Research
Ethics & Social Justice in Health Research Involving Vulnerable Adolescents looks at the dilemmas in youth research regarding autonomy and access. the seminar gives examples on implementing goodness of fit model in human subjects research in adolescents.
Quality Management
IPPCR: Quality Management in Clinical Research addresses the regulations and guidance for QM, the purpose of quality management and how this is implemented in research.
Recruitment and Retention
The goal of Pediatric perspective for recruitment, enrollment, and retention of clinical trials is to provide lessons learned regarding the inclusion of pediatric populations in clinical studies, with evidence-based practical advice to the scientific community.