- This Core conducts quality improvement/good clinical practice guideline audits to provide onsite guidance to PRCTRC researchers and determines state of compliance with regulations, institutional policies and Institutional Review Board requirements.
- Develops educational/assistance programs to help PRCTRC researchers develop regulatory review/submission documents and informed consent forms.
- Ensures that conflicts of interest are eliminated or managed appropriately, and develop a Data Safety Monitoring Board that will ensure compliance with the highest ethical standards ensuring hence that the protection of the human subjects enrolled in the trials are guaranteed.
RKS Specific Aims
- Ensure maximum protection for human research subjects, and assure that all PRCTRC research projects and activities are in compliance with federal policies and regulations.
- Ensure that all PRCTRC researchers are trained in the science and ethics of research human subjects in order to optimize study design, facilitate regulatory review, understand the informed consent process and uphold transparency in conflict of interests in clinical and translational research.
- Stimulate the generation of independent research projects, which evaluate barriers in the informed consent that mediate and influence Hispanic participation in research activities in Puerto Rico.
- Ensure the continuity and the ongoing process of the reciprocity among the three IRBs of the Consortium institutions.
- Provide administrative oversight to ensure maintenance of high ethical standards and regulatory compliance in clinical and translational research activities among PRCTRC.
- Oversee the review process for request PRCTRC services.
- Monitor the IRB reciprocity agreement among PRCTRC institutions.
- Provide orientation, support, and technical assistance in regulatory aspects among PRCTRC investigators.
Research Training Certificates
Investigators requesting services from the PRCTRC must complete required trainings (click here) related to the regulatory aspects of research. Investigators must check with their home institution for the source and availability of these trainings.
The PRCTRC conducts required audits on all IRB approved studies to assure that investigators follow all the necessary steps to warrant the safety of subjects participating in research studies supported by the Consortium. Audits also warrant that studies are performed according to approved protocols by the Institutional Review Board (IRB).
- Informed Consents – The informed consent document provides a summary of the clinical trial (including its purpose, the treatment procedures and schedule, duration, potential risks and benefits, alternatives to participation, key contacts). The informed consent process consist of explaining the study to the prospective participant, the Principal Investigator or the authorized person conducting the process, with ongoing explanations that will help the participant decide whether or not to sign the document. The Institutional Review Board (IRB) must approve (stamp and date) all consent documents to be used. Approval must also be obtained from the IRB for each modification/change made in the consent form at any time after a study has initial IRB approval; changes in study protocol must be submitted and approved by the IRB prior to implementation of these changes. The version of the consent document being used should match exactly with the version given final IRB approval in the regulatory binder.
- Participant Record – All documents that substantiate data collected and/or are relevant to a subject’s participation in a clinical investigation constitute a research record. Proper record keeping is fundamental to the validity and reliability of data collected during research. One of the most common findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. It is the Principal Investigator’s responsibility to oversee the general organization and design of study records, both paper and/or electronic, to ensure that the study results are built on the foundation of credible and valid data.
- Regulatory Binder – The Regulatory Binder contains all study-specific information and regulatory documentation. The Principal Investigator is ultimately responsible for maintenance of the regulatory files, although this task can be delegated to other member of the research team. Organizing these essential documents allows research team members to reference information and also allows easy access to essential documents by trial monitor, auditors, IRB representatives, or regulatory authorities (e.g. OHRP, FDA, etc.) for review/audit purposes. The storage location needs to be secure, whether study documents are stored in a binder or electronically.
For more information regarding the construction or maintenance of the regulatory binder, please access the following links:
RKS Standard Operating Procedures
Helpful tools for regulatory documentation:
- Adverse Event
- Audit at the PRCTRC
- Conflict of Interest
- Data Safety Monitoring Plan
- Personnel Log
- Informed Consent Process
- IRB Reciprocity
- Protocol Expired IRB
- Study Initiation Meeting
- Training and Education for the Research Team
- Biohazard definitions SOP
- Biological Spills SOP
- Biomedical Waste SOP
- Blood Collection SOP
- Colposcopy and Punch biopsy collection SOP
- First Aid Procedure-1
- SOP Checklist
- Handling and transporting LN2 SOP
- Packing and Shipping Samples
- Saliva Collection Method
- Transportation Biological Specimens
- Universal Precautions
Helpful links for investigators:
- Financial Conflict Interest NIH Tutorial
- UPR Disclosure of Investigators’ Significant Financial Interest (FORM 1.A)
- UPR Disclosure of Investigators’ Significant Financial Interest (FORM 1.B)
- UPR Financial Conflict of Interest Annual Disclosure (FORM 2.A)
- UPR Financial Conflict of Interest Disclosure Attachment (FORM 2.B)
- Investigational Device Exemption Application (IDE)
- Investigational New Drug Application (INDs)
- Office for Human Research Protections (OHRP)
- PHS 398 Biosketch Format