The Human Study Lifecycle

Amendments

Investigators may not initiate any changes in researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.   protocolProtocolstep-by-step details of how a study will be conducted including objectives, design, procedures, measurements, management and analysis, as well as a discussion of relevant research ethics issues.  , procedures or consentConsentis a person's voluntary agreement to participate in research.  form(s) without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject.

• Submit the request to the UTHSA IRB Office.

IRB Progress Report

The appropriate Progress Report should be submitted to IRBmail@uthscsa.edu for studies with an IRB regulatory expiration date on your most recent IRB approval letter.  The PI should be copied on the submission email.

Select the appropriate report:

• Progress Report Form
• Repository Progress Report Form
• HDE Progress Report Form

Institutional Update Report

An Institutional Project Update Form should be submitted to OCRmail@uthscsa.edu for:

• UTHSA IRB studies with a UTHSA institutional expiration date on your most recent IRB letter. The PI should be copied on the submission email.

Prompt ReportPrompt ReportA PI report notifying the institution and the designated IRB or IACUC when specific urgent issues are identified.  

Submit UT Health San Antonio Prompt Report form (REDCap Survey)

Use this flow chart to guide you on the submission process to the IRB and OCR

ExceptionExceptiona one-time, intentional action that departs from the IRB approved protocol for a single subject. An exception is identified before it occurs and is under the control of the investigator.   Request

Single subject exceptions may not be initiated without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject.

A single Exception Request Form should be submitted to IRBMail@uthscsa.edu for review and approval.  The PI should be copied on the submission.

Reactivation

A PI may request the IRB consider re-initiating research previously voluntarily inactivated by the PI if no research activity has occurred after the inactivation date and the research activities are limited to minimal riskMinimal RiskThe probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For VA studies the determination includes tangible or intangible risk. For DOD research the determination does not include the inherent occupational risks that certain subjects face in their everyday life.   procedures.

Note: The IRB will review the document and decide on a case by case basis whether the study can be re-initiated. 

The Request for Re-activation form should be submitted to IRBmail@uthscsa.edu.  The PI should be copied on the submission email.

Change to Velos eResearch 

Submit the CTMS Change Request form to clinicaltrials@uthscsa.edu

Amendments

Investigators may not initiate any minor or major changes in researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.   protocolProtocolstep-by-step details of how a study will be conducted including objectives, design, procedures, measurements, management and analysis, as well as a discussion of relevant research ethics issues.  , procedures or consentConsentis a person's voluntary agreement to participate in research.  form(s) without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject. 

• Are the requested changes regulatory issues? Submit the request to the IRB of RecordIRB of Recorddenotes the IRB responsible for approval of a specific research study at a given institution.   using their policies and procedures. 
   
• Are the requested changes institutional issues? Submit the request to the UTHSA OCR for institutional review/approval. 

Progress Report

Submit to the IRB of Record using the external IRBExternal IRBAn IRB operated by an organization other than UTHealthSA   's policies and procedures.

Institutional Update Report

An Institutional Project Update Form should be submitted to OCRmail@uthscsa.edu for External IRB studies with a UTHSA institutional expiration date on your institutional activation or project update letter. The PI should be copied on the submission email.

Prompt ReportPrompt ReportA PI report notifying the institution and the designated IRB or IACUC when specific urgent issues are identified.  

A prompt report should be submited to the IRB of Record according to their policies and procedures.  Copy OCRmail@uthscsa.edu on the submission.

 Use this flow chart to guide you on the submission process to the IRB and OCR

Change to Velos eResearch 

Submit the CTMS Change Request form to clinicaltrials@uthscsa.edu

Personnel Changes

Adding or removing a member of the study team may require varied notifications. 

Generally applicable to funded research covered under an existing agreement or contract with a funding entity, study sponsorSponsorare the agencies, institutions, companies, organizations, foundations, or individual grantors responsible for the initiation, management, or financing of a research study.   , or a service providerService Providera clinical department, clinic , hospital or provider who has agreed to perform specific procedures outlined in the study plan (e.g., imaging by radiology or consults with specialists).   .

Changes to the study plan, performance sitePerformance Sitea physical location where research activities or protocol-directed procedures are performed.  , service provider, study team, funding source or participant payment plan often may require modification of the existing agreement, MOU or contract. 

Contact OSP for modifications to grant funded researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.   .  

Contact CTO for modifications to industry sponsored research.

Change to Velos eResearcheResearchVelos eResearch is UT Health San Antonio's designated Clinical Trial Management System (CTMS). Velos eResearch is a web-based application designed to centralize the management tasks needed to conduct a clinical trial including study statuses, subject enrollment and activity, study calendars, budgets and billing.  submit the CTMS Change Request form to CTMS-Support@uthscsa.edu

Billing Industry Sponsors

• Proper billing of industry sponsored research requires knowledge of the budget and payment terms and conditions of the contract, and awareness of the status of researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.   activities as they relate to the invoicing triggers.  

• The PI and research team is responsible for documenting study activity, specifically milestones that trigger budget payments using Velos eResearch. 

• The PI’s Department (or Institutional Organized Research UnitInstitutional Organized Research Unitprovide support for interdisciplinary research that complements the academic goals of departments of instruction and research (i.e., institutes, laboratories, or centers.   ) is responsible for billing and reconciling payments according to the terms and conditions of the contract.  Each department must maintain a system of records documenting invoicing, payments and other reconciliation activity. 

• All payments from sponsors must be processed for applicable Facilities and Administrative (F&A) cost by OSP. 

UT Health SA Service ProviderService Providera clinical department, clinic , hospital or provider who has agreed to perform specific procedures outlined in the study plan (e.g., imaging by radiology or consults with specialists).   Billing

• Proper billing for clinical services provided in research requires knowledge of the terms and conditions of the agreement, and awareness of the current status of support activities provided. 

• The UT Health SA Service Provider is responsible for tracking invoiceable activity, billing the research and reconciling payments according to the terms of the agreement.  Each Service Provider must maintain a system of records documenting invoices, payments and other reconciliation activity. 

• Research activity captured on EPIC Workbench Reports will be assessed at least once a month by the designated EPIC Special Accounts team.  The Special Accounts team is responsible for billing the research charges according to the terms of the study service agreement on file.

Responsibilities:

• When a local investigator holds an INDINDInvestigational New Drug application with the FDA.   or IDEIDEInvestigational Device Exemption filed with the FDA   , they are known as a sponsor-investigatorSponsor-Investigatoris an individual who both initiates and conducts a clinical investigation and under whose immediate direction the investigational drug/device is being administered, used or dispensed. For administrative reasons, only one individual should be designated as the sponsor. Usually, the intent of the sponsor-investigator IND/IDE is to gain scientific knowledge without seeking market approval for the drug or device. These are considered 'Investigator-Initiated' or sponsor-investigator IND/IDEs.   . Sponsor-Investigators assume the sponsor responsibilities for the study, such as ensuring the study is monitored and regular reporting to the FDAFDAabbreviation for US Food and Drug Administration.  . It is the investigator’s responsibility to review and familiarize themselves with FDA regulations outlined in 21CFR312 (as additional responsibilities are listed), Good Clinical Practice (GCP) Guidelines ICH E6, and any other regulations and policies that may apply. ​​

• OCR has investigator services to assist with sponsor-investigator responsibilities and monitoring activities.  Contact the OCR for assistance: OCRMail@uthscsa.edu; 210-567-8555

  To assist with maintaining sponsor required records and documenation the following Sponsor Investigator Templates are available:

  • -Monitoring Plan Template
  • -Monitoring Visit Log
  • -Sponsor Investigator Checklist

Sponsor MonitoringSponsor Monitoringongoing assessment of performance sites by the sponsor (or CRO) of a clinical investigation to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the clinical trial data submitted to FDA.    - Onsite and Remote MonitoringRemote Monitoringmonitoring or auditing a study while not physically present on the UT Health campus.  

Sponsor/CRO requests for onsite monitoringOnsite Monitoringmonitoring or auditing a study while on the UT Health campus.   must be documented. 

How monitors access subject records depends on the institutional requirements were the study is being conducted.

A.  Onsite Monitoring at UTHealthSA

The PI or study team are responsible for arranging space, meeting schedule, access to study records. 

For visits of more than three (3) consecutive days, study staff must ensure the monitor obtains a POI “person of interest” designation and criminal background check.  

For more information see the Handbook of Operating Procedures (HOP) policy for obtaining a POI designation and criminal background check at Section 8.7.11, “Contractors and Vendors”.  

B.  Cancer Related ResearchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.   : Access to Health Records (UTHealthSA EPIC) and Regulatory Documents (Complion)

Submit the "Research Monitor Visit Request" form to the Mays Cancer Center Monitoring Administrator.

Questions regarding sponsor monitor access?

Mays Cancer Center - Mays-CC-Monitoring@uthscsa.edu

C.  Non-Cancer Related Research:  Access to Health Records (UTHealthSA EPIC)

Submit the "Research Monitor Visit Request" form to the VPR CTO Monitoring Administrator.

Questions regarding sponsor monitor access to Epic?

Non-Cancer Research - VPRCTO@uthscsa.edu

Access to regulatory documents in Complion for noncancer studies are controlled by the study team.

D. Sponsor Monitoring at University Health 

Complete the UH online request form to schedule onsite monitoring

Institutional Office of Compliance and PrivacyPrivacycontrol over the extent, timing and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.  Audits

The Institutional Office of Compliance and Privacy conducts periodic audits of IRB-approved research conducted by UT Health San Antonio researchers. The goal is to achieve and maintain compliance with organizational policies and applicable laws, regulations, codes and guidance. Through periodic compliance reviews and other quality improvementQuality Improvementsystematic, data-guided activities designed to bring about immediate, positive changes in the delivery of health care in particular settings. QI involves deliberate actions to improve care, guided by data reflecting the effects QI is generally not considered research Ð however, QI activities can be research if they are also intended to contribute to generalizable knowledge.   activities, the Compliance program evaluates and makes recommended improvements to increase compliance, when necessary.

Learn more about the Institutional Office of Compliance and Privacy Auditing Program

UT Health San Antonio strives to create a researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.   climate that promotes adherence to high ethical standards without inhibiting the productivity and creativity of persons involved in research.  ​​​

If you have concerns regarding Research MisconductResearch MisconductFabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.    (i.e., fabricationFabricationMaking up data or results and recording or reporting them.   , falsificationFalsificationManipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.   or plagiarismPlagiarismincludes both the theft or misappropriation of intellectual property and the substantial unattributed textual copying of another's work. (see detailed definition for specifics)   ) you should contact the Research Integrity Officer (RIO), Joseph Schmelz, PhD at schmelz@uthscsa.edu

Learn more about the Research Integrity Program