Clinical Trials Playbook

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Check all of the elements below that apply to your research study and click submit; you will be guided to offices you may need to consult in order to ensure full regulatory compliance in trials implementation.

My study involves:


HRPO - Human Research Protections Office (IRB)

Provides review and approval for research protocols and has processes in place to follow if you wish to cede review to another IRB or request that the PITT IRB act as the central IRB of record for a multi-site study. An online submission process is available.

http://www.irb.pitt.edu/

Trial Innovation Unit

CTSI has clinical trials experts ready to answer questions and assist with problem solving to promote the efficient implementation of clinical trials. For assistance obtaining consultation, contact Sue Clifton: cliftons@pitt.edu.

ACT Cohort Discovery Tool

The ACT program is creating a federated network of CTSA sites to enable cohort discovery across the nation in real time using a web interface without needing study-specific IRB approval. The ACT Cohort Discovery Tool will enable investigators to obtain aggregated patient counts and patient demographic breakdowns across the network by constructing queries using terms consisting of standard terminologies. For more information about ACT, visit here.

03IS – Office for Investigator-sponsored IND and IDE support

Provides assistance, review, and approval for studies which involve an investigational drug or device. IND and IDE applications are submitted through O3IS. http://www.o3is.pitt.edu/

Institutional Biosafety Committee / IBC Office

The IBC reviews all research proposals involving recombinant or synthetic nucleic acid molecules, ensures compliance with NIH guidelines. Applications can be submitted online using MyIBC – personalized training available through IBCO.

http://www.ibc.pitt.edu

NIH rules regarding what constitutes a clinical trial are undergoing changes

Some types of research that formerly were not considered to be clinical trials may meet the new definition. Additionally, starting in January 2018, NIH funded multi-site trials will be required to designate a single IRB of record. Please consult the following links for guidance, and remember that all NIH-funded clinical trials must be registered with clinicaltrials.gov.

https://grants.nih.gov/policy/clinical-trials/definition.htm

https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm

Human Stem Cell Research Oversight

Human Stem Cell Research Oversight Committee is administered through the Institutional Biosafety Committee. hSCRO reviews and approves human embryonic stem cell research as well as certain other types of stem cell research. They ensure studies are compliant with ethical guidelines and state and federal regulations.

http://www.ibc.pitt.edu/hscro

Radiation Safety Office

Provides mandatory radiation safety training for researchers using radioactive materials or radiation producing equipment. Responsibilities of the office include Maintenance of radioactive materials and accelerator licenses and X-Ray machine registrations.

  • Radiation safety training
  • Personnel radiation monitoring
  • Receipt and inventory of radioactive materials
  • Radiation surveys and compliance audits
  • Clinical radiation physics support
  • Radiation safety procedure design and review
  • Radioactive waste disposal

http://www.radsafe.pitt.edu

Office for Oversight of Anatomic Specimens / Committee for Oversight of Research and Clinical Training Involving Decedents

CORID reviews and approves proposed research that require the use of human cadaveric material and decedent medical records. Provides ethical oversight. http://www.ooas.pitt.edu

Office of Export Controls

The OEC houses the Export Controls Officer; ensures imports and exports are in compliance with federal regulations. Determines when licensing agreement is needed and assists with completion of additional documentation required under a license application.

http://www.export.pitt.edu

Qualtrics / REDCap

REDCap (Research Electronic Data Capture) is a secure, Web-based application designed to optimize clinical trial data collection. At the University of Pittsburgh, it is provided at no cost for use with any IRB-approved research project

Qualtrics: The University has a site license for the Qualtrics survey system, which is available to PITT faculty, staff and students and no cost. This cloud-based research tool has been vetted and approved by Pitt’s Office of General Counsel and Information Security Officer

More information about these two systems can be found here: http://www.ctsi.pitt.edu/research-berd-resources.html

Data Use Agreements (DUA):

A DUA is a contractual agreement that sets parameters around the allowable use and disclosure of data shared between institutions for research purposes. DUAs also address issues around liability for harm arising from use of data; publication, and privacy rights. DUAs help protect confidentiality while allowing for the sharing of research results.

Information about DUAs and instructions for submitting a DUA at PITT can be found here: http://www.research.pitt.edu/ccc-data-use-agreements

Materials Transfer Agreements (MTA)

MTAs are contractual arrangements used for sharing of biological and research materials between institutions. Terms regarding use of research results, ownership of technology generated by the research, and use of research results are typical areas of negotiation to reach contract terms.

More information about MTAs and instructions for initiating an MTA submission can be found here: http://www.research.pitt.edu/ccc-material-transfer-agreements

Electronic Health Record Research Request (R3)

Health Record Research Request (R3) is a service of the Department of Biomedical Informatics (DBMI) managed by the Chief Research Informatics Officer (CRIO), sponsored in part by the Clinical and Translational Sciences Institute and Institute for Precision Medicine. Pitt and UPMC desire to make clinical data available for research. Under the CRIO, on behalf of UPMC, DBMI staff provision data for research (in some cases as Honest Brokers). R3 is this service or process of obtaining UPMC clinical data and of authorizing additional UPMC data sources for research. R3 is available for use by researchers of the University of Pittsburgh, and for UPMC projects requiring research datasets. For more information about R3, visit the Research Informatics Office website.

MyRA / Office of Research

Online application for submission of Materials Transfer Agreements, Data Use Agreements, and Confidentiality Agreements. Online Application Link

Office of Sponsored Programs and Research Support

Supports and administers industry funded studies. Interprets sponsor rules, provides post-award administrative services. http://oorhs.pitt.edu

ClinicalTrials.gov

ClinicalTrials.gov is a registry over 240,000 studies with locations around the world. All applicable clinical trials are mandated by law to register and share outcome information on ClinicalTrials.gov. More information on which trials are required to register can be found here:

https://clinicaltrials.gov/ct2/manage-recs/fdaaa

For questions and assistance contact: CTgov@pitt.edu.

Genomic data sharing guidance

For NIH funded studies involving genomic data, the NIH has a specific policy around data sharing. The Genomic Data Sharing policy (GDP) requires sharing of large-scale human or non-human genomics data, including genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, metagenomic, epigenomic, and gene expression data. A genomic data sharing plan should be included in the resources sharing plan section of NIH grant applications.

The NIH Genomic Data Sharing Policy can be found here:

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html

Guidance from the University of Pittsburgh Office of Research can be found here:

http://www.research.pitt.edu/new-genomic-data-sharing-policy-november-2014

Single IRB review Guidance:

Conversely, to request that the University of Pittsburgh serve as the IRB of record for multiple sites, complete and submit the form, Initial Application for Pitt to Serve as IRB of Record. If HRPO determines it is willing to act as the IRB of record, you will be asked to provide more information regarding each study site in order for the reliance agreement process to proceed.

Many multi-site research studies utilize a single IRB of record to provide regulatory oversight; in fact, the NIH will require Central IRB review for all NIH funded studies beginning in January 2018. Here at the University of Pittsburgh, the Human Research Protection Office (HRPO) has procedures in place for both ceding IRB review to another institution and accepting responsibility as the IRB of record for other institutions. Research studies requesting to cede review to an outside party should visit the HRPO website and complete and submit the brief form, Application for an External Institution to Serve as IRB of Record. If HRPO approves the request, this begins the process which leads to the execution of a formal reliance agreement. It is important to note that a reliance agreement ceding IRB review does NOT remove the responsibility of the local institution for oversight of all other aspects of human research protections, such as ensuring research team compliance with all responsible conduct of research trainings and ensuring there are no conflicts of interest on the part of research faculty and staff.

Studies that plan to use a single IRB of record should consult with the HRPO prior to grant submission to ensure all related budgetary issues are addressed prior to funding.

Further details can be found on the HRPO website: http://www.hrpo.pitt.edu/reliance-agreementssingle-irb-review

Confidential Disclosure Agreement/Non-Disclosure agreement (CDA/NDA)

CDA/NDAs are legal agreements which outline information parties wish to share with one another, but wish to restrict from wider use and dissemination. By signing, parties agree not to disclose the non-public information covered by the agreement. At the University of Pittsburgh, which office reviews a CDA/NDA is determined by the content and purpose of the agreement. Please see this guide from the office of research for assistance determining where and how these agreements should be routed:

http://www.research.pitt.edu/ccc-confidential-disclosure-agreement-cdanon-disclosure-agreement-nda