The ECS-HSR Division offers virtual clinical research consultations to Sponsor-Investigators and clinical research teams. The purpose of these meetings is to enhance the knowledge of Good Research Practices and the Regulations that govern Human Subject Research.
The following are a few consultation services offered by our experienced research professionals:
New Sponsor-Investigator Meeting
The purpose of this meeting is to discuss FDA sponsor responsibilities with investigators acting as the sponsor of an investigational drug or an Investigational Device Exemption. The following may be discussed, but is not limited to:
- Regulations for Humans Subject Research and Clinical Trials,
- Resources available to the sponsor-investigator,
- Monitoring plans,
- Requirements for registration and reporting on ClinicalTrials.gov, and
- Conflict of Interest.
Email ECS-HSR@pitt.edu to request a New Sponsor-Investigator consultation with our Assistant Vice Chancellor for Research Protections, Mara Horwitz, MD.
New Research Coordinator Meeting
This individualized meeting is for new research coordinators interested in learning how their role may interact with the ECS-HSR Division and the Office of Research Protections (ORP). The following may be discussed as a brief overview, but is not limited to:
- A brief overview of PittPRO,
- Maintenance of regulatory and subject files,
- Abbreviated review of Good Clinical Practices, and
- Review of services provided by ECS-HSR and ORP
Email ECS-HSR@pitt.edu to request a New Research Coordinator consultation with one of our research professionals.
Multicenter Guidance Meeting
The purpose of this meeting is to assist investigators and their study teams with the Multicenter Application process. The following may be discussed, but is not limited to:
- Assistance with completing the Multicenter Application,
- Planning for Sponsor oversight of the external sites,
- Planning for external site monitoring, and
- Planning for Coordinating Center activities.
Email IIS@pitt.edu to request a Multicenter Guidance consultation with an experienced research professional.
Human Research Study Start-Up Meeting
The purpose of this meeting is to provide clinical research investigators and/or their study teams an overview of the study start-up process and introduce the principles of good clinical practice. The Human Research Study Start-Up Checklist is a tool to help guide study teams through the study start-up process. The following may be discussed, but is not limited to:
- Required Collaborative Institutional Training Institute (CITI) Training
- Study-specific Training
- Child Clearances
- Regulatory Documents
- Reporting Responsibilities
- Informed Consent Process/Documentation
- Source Documentation
- Data Security and Data Retention
- Ancillary Accounts
Email ECS-HSR@pitt.edu to request a Human Research Study Start-Up consultation with one of our research professionals.
Regulatory File Maintenance Meeting
The purpose of this meeting is to assist study teams with planning for the creation, organization, and maintenance of a regulatory file. The Guideline: Study Documentation for FDA Regulated Research and Clinical Trials is a helpful resource for identifying the necessary record-keeping requirements. The following may be discussed, but is not limited to:
- Required Content
- Documentation Updates
- Record Storage and Retention
Email ECS-HSR@pitt.edu to request a Regulatory File Maintenance consultation with one of our research professionals.
Clinical Trial Registration Meeting
If you have questions or concerns that you would like to discuss with our ClinicalTrials.gov Administrator regarding the registration of your study, maintaining the record, submitting results, or responding to QC comments, please send your request to CTgov@pitt.edu.