Clinical Trials Toolkit
Welcome to the PORTICO clinical trials toolkit. To complete a module, select from the buttons below to be sent to the section of the page containing the video(s) and informative links. Once you have finished with the module, you can go back to the module list by selecting "Back to Topics" or you can navigate through the entire page of alphabetically arranged modules by scrolling through the page.
Advanced Modules are also offered for those investigators seeking specialized knowledge.
When you have completed the modules, please provide feedback: https://redcap.link/PORTICO_toolkitfeedback Completion of the toolkit feedback survey will trigger a certificate of completion to be sent. If you have any questions about the toolkit or certificate of completion, please contact us at: portico@cchmc.org.
Audit and Inspections
The seminar describes the FDA inspection process from pronouncement to closeout meeting, including common findings.
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Clinical Trial Registration
Clinicaltrials.gov is a web based repository of clinical study required as the result of the Food and Drug Administration Moderniztion Act of 1997. This information is maintained by the NLM and NIH.
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Data and Safety Monitoring
This NIH seminar provides an introduction, examples, basics, and samples of monitoring from DSMBs.
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Good Clinical Practices
Good Clinical Practices or GCP is the international standard by which clinical trials are conducted. The ABCs of GCP provides a quick overview of GCP and the 13 Principles of ICH, while the GCP Webinar video goes into more depth.
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HIPAA & Privacy
The Health Insurance Portability and Accountability Act regulates the way certain data known as protected health information (PHI) is handled. It is important that researchers know the rules surrounding use of PHI.
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Informed Consent
Informed Consent is an essential process in clinical research that allows the subject to make an informed decision about participating in research. The video below discusses the elements of consent. For more on consent in pediatric population please see section Informed Consent-Assent.
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Informed Consent-Assent
Assent is the consent process for persons who are too young to give informed consent but are able to understand the research study. The Understanding Pediatric Assent and Ethical Considerations in Conducting Pediatric Research video is a good review of the process.
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Advanced Special Topics: Coming Soon
Investigator Role
This video provides a quick historical/legal background while highlighting the responsibilities of the investigator in the research project.
For more information:
Investigator Responsibilities in Clinical Research
Pediatric Research: PI Responsibilities
Institutional Review Board
The Institutional Review Board (IRB) is a committee responsible for reviewing research involving human participants to ensure the protection and welfare of human research subjects. This OHRP seminar reviews the basics to prepare you for your submission to the IRB.
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IRB Reliance
Federal policies now require certain types of federally-funded multi-site research to use one IRB for review and approval for all sites. The video below describes the history and application of these policies.
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Multi-site trials
This video provides an overview of the challenges of managing Multi-site trials from an early investigator prospective.
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Pediatric Research
Pediatric participants in research are considered vulnerable populations. The video below reviews the ethical underpinnings of research in the pediatric population utilizing real world examples.
For more information:
How to Conduct Clinical Trials in Children: A Tutorial
Ethical Conduct of Research in Children
Advanced Topics: Pediatric Research
Protocol and MOOP
The research protocol and the Manual of Operating Procedures are documents that facilitate consistency in research by detailing the study’s conduct and operations. The videos describe the purpose and development of these important documents.
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Records/Source Documents
Good Records and Source Documents are the key to good research data. This video provides a framework for good documentation practices for research.
For more information:
Source Documents and Case Report Forms: Forms and Function
Advanced Topics: Data management
Recruitment and Retention
Without participants investigators will not be able to answer their research questions. The short video below provides an introduction to patient engagement to help develop research with recruitment and retention in mind.
For more information:
Best Practices for Pediatric Recruitment and Retention
Advanced Topics: Recruitment and Retention
Regulations-Electronic Systems
If your study is being completed as part of an IND or IDE or your grant specifies, you may need to ensure the data you collect is in compliance with 21CFRpart11. The video below provides a short introduction to the rule.
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Safety-Adverse Events
An important investigator responsibility is monitoring the safety of your research. The videos introduce the adverse event monitoring and the reporting database used in FDA trials.
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Advanced Topics: Safety Reporting
Safety-Unanticipated Events
The OHRP videos below delve into the reporting of unanticipated events. An unanticipated event is an issue that is unexpected, related to the research and places research participants at risk of greater harm.
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Study Design
In order to ensure your research meets your objectives a solid study design is required. The first video describes the process and phases of clinical research. The second video focuses on designing a high quality study.
Advanced Topics: Study Design
Trial Essential Documents
Essential Documents are an important part of ensuring research is being done is a qualitative and compliant manner. These documents are outlined in the video below and listed in the ICH essential documents link.
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Advanced Topics: Investigator Forms
Statisticians and Data Management
Good statisticians are an essential part of the research team. Watch the video below to learn more about working with statisticians on your research project.