Research Protocol & IRB Instructions

Research Credentialing, Applications, Data Requests & CITI, USF, IRB Registration

CITI

TGH CREDENTIALING

  • If you are not a TGH research employee, USF research employee, already affiliated research member, medical student, resident or attending physician at TGH or USF, you need to complete TGH credentialing

RETROSPECTIVE CHART REVIEWS 

Retrospective Chart Review Study Protocol Template

Study Protocol Title: Be consistent with the Title through out your application, protocol and the regulatory documents

Table of Contents:

List of Abbreviations: Use commonly used abbreviations and acronym.

Principal Investigator, Research Team, and Study Site: Principal investigator: Co-Investigators, Research team and contact Information: Study site:

Research Synopsis
Study Title Enter the full title
Study Population Include a brief description of the population such as health status, gender, age, etc. Study Design

Study Design Present an overview of the study design for example, retrospective chart review, data or specimen collection etc

Sample Size Include total number of patients or charts for the study including other sites.

Study Duration Length of time to review charts, data collection, and analysis till the completion of the study

Primary Objective Include primary objective and outcome measures

Secondary Objectives Include secondary objective and, outcome measures

Background and Significance: This section is based on your research question. How are the possible answers to the question explained and defended? What are assumptions and relationships? What are the working hypotheses? Justification of your conducting this study based on existing knowledge and your research question.

Describe the disease including incidence. Provide a summary of previous pre-clinical studies, relevant clinical studies, or any epidemiological data if available
Include references with citations from the literature.
In the last paragraph state the main purpose of the study summarizing all the information provided in your background section.

Objectives: These should be defined after the theoretical outline has been developed. The sequence should be clear between the primary question and possible responses to the questions or hypotheses. The objectives are the intellectual activities that the investigator will perform throughout the research study.

Primary Objective Include the details of your primary objective (which is your main purpose of performing this study and should be focused on one question), outcome measures and method by which outcomes will be determined. Sample Text: To evaluate the efficacy of antibiotics in the treatment of acute bronchitis

Secondary Objectives Include secondary objectives which can be two or three can be dependent or independent of the primary objective, outcome measures and method by which secondary outcomes will be determined. Sample text: To assess patients overall change in symptoms and return to daily activities after 2 weeks of antibiotic treatment to evaluate management and treatment factors as potential predictors of outcome.

Study design/methodology: Include the description of study type, for example prospective data or specimen collection, retrospective, or observational, survey, or questionnaire; Type of study and design should be decided on the basis of proposed objectives and the availability of the resources.

The methodology explains the procedures that will be used to achieve the objectives. In this section the definition for the variables used should be specified in detail, along with the type of variables and the ways to measure them. Example text: This is a retrospective chart review of patients treated for …..with…. .

What kind of data will you be collecting to measure your primary and secondary outcomes?

Study Population: Details of the population to be included in the study

Inclusion /Exclusion Criteria

What are the criteria for including or excluding any particular population?
Include enrollment of subjects with diverse racial and ethnic backgrounds to ensure an equitable selection.
Study Duration/ Study Timeline:
Briefly state the stages of your study for example,
Stage 1, review of medical records —-4-6 months
Stage 2, data collection and data analysis
Stage 3, presentation and publication…

Project Start and End Date: Include a projected start date. Provide the total length of time and include an approximate end date of the study. It is convenient for the reviewer to see the events of the study schedule or duration in the form of a flow chart.

Statistical Analysis Plan: What do you plan to analyze from the data you collect? Consult a biostatistician before you finalize your protocol.
Sample size determination What sample size will you be able to get and if your suggested samples size has enough of power to deliver the significant results? Include the number of charts you are planning to review. For multi-center studies, include the total number of sites expected and the total number of subjects to be included across all sites. Provide the rationale for the sample size, the calculations on the power of the trial and the clinical justification. Include plan of accounting for missing, unused and spurious data
Informed Consent Process: In case of retrospective chart reviews an application for the waiver of consent form can be filled out depending upon the IRB criteria of review (expedited, exempt, full board). In case of a prospective data collection, include information about the regulatory requirements of the consent form and which languages will be used. For Spanish speaking population a Spanish consent form should be included. The language and writing of an informed consent is usually at a 6th grade level.
If potentially vulnerable subjects will be enrolled in the study for example pregnant and lactating women, children, prisoners, cognitively impaired and critically ill subjects, include a justification.
Privacy and confidentiality: Sample language: Human subject’s names will be kept on a password protected database and will be linked only with a study identification number for this research. There are no patient identifiers. All data will be entered into a computer that is password protected. Data will be stored on a cloud based, HIPAA compliant platform called RedCap and no data will ever be stored on a personal computer. The initial data file will be obtained from IT and then accessed using TGH password protected email and a password protected computer by the PI. The data will be uploaded to RedCap immediately and then deleted from the TGH computer. The data will be analyzed using online office tools and statistical packages. Any physical documents or printed documents will be maintained in a locked filing cabinet accessible only by the study personnel and located in the office of the Medical Director of Clinical Research (Jason Wilson) at Tampa General in Room 2034K. All data will be stored on RedCap for 5 years after study completion. Data in the locked filing cabinet will also be stored for 5 years. All data will be destroyed 5 years after study completion.  (Some institutions have different time frame for the storage of data. Check institutional SOPs)

Risk/Benefit:

Risk to participants:

Identify any risks involved while conducting the study

Benefits to Participants

Include any benefits to the participant or to the overall research field
Sample text: This study does not present any direct benefit to the participants. However the study does provide an opportunity to gain a better understanding of …………………..
Data Safety Monitoring: Monitoring is an ongoing review of the study throughout its duration. Any action resulting in a temporary or permanent suspension of the study should be reported to the IRB and to the Office of Clinical Research. The PI is responsible for reporting any reasons outside the planned study design such as incompliance with the protocol or if there is any delay in the initiation of the study due to administrative reasons.

Conflict of Interest: Clearly document any consultative relationship that the principal or co-investigators has with a non-USF entity related to the protocol that might be considered an apparent conflict of interest. Depending upon the type of conflicts, these can be managed accordingly.

Publication and Presentation Plans: List any meetings or conferences where you will be presenting the data and the results of your study.
References:
List all the references used in the back ground section at the end of the protocol. Endnote and Reference Manager are the software tools for publishing and managing bibliographies and are used frequently for citations and managing your own libraries.

RETROSPECTIVE/EXPEDITED IRB

  • there is a template attached here and illustrated below to use as a guide for IRB submission
  • Create an eIRB account
  • Use the TGH or USF email account so the system recognizes you as a TGH employee/USF employee or student, and thus a USF affiliate
  • ALL study investigators must have a registered eIRB account
  • List TGH as your affiliation if you are doing any TGH patient related work or chart reviews at TGH
  • Ensure that anyone and everyone (e.g. Co-investigators/Faculty Advisor and Key Personnel) involved in your project has completed the above steps.
  • you will be asked to upload your proposal, data collection form, and CV so have these documents completed and ready for submission
  • When you submit your study to IRB, your project will first be routed to TGH’s office of clinical research (OCR) for the initial review.  Email Jason Wilson, MD when this occurs to facilitate more timely movement of this process.  The OCR will review your proposal and forward their approval electronically to the IRB for their review.
  • Most IRB questions will be addressed in a well written proposal
  • Requested IRB Review Type (e.g. Exempt, Expedited, Full IRB Review). Do NOT pick exempt bc IRB does not accept exempt reviews anymore. All projects are either expedited or full review.
  • Expedited Qualification Chart reviews #5, Survey studies #7, QI projects #5 and #7
  • Research type: Survey studies fall under social behavioral; All others fall under Biomedical.
  • You must click the button on the IRB application that alerts other study team members to participate. The system will NOT automatically send your Co-investigators/Faculty Advisor and Key Personnel an email thus you must do this yourself by clicking the highlighted section below. Study members will then receive an email where they must acknowledge agreement to participate in the study.
  • Answer ALL questions

Retrospective Chart Review Study  IRB Application Template

Use the attached retrospective IRB application template or information contained in the figures below to complete a retrospective chart review, expedited IRB application

TGH RETROSPECTIVE STUDY APPLICATION & DATA REQUEST FORM (AFTER PROTOCOL CREATION AND IRB APPROVAL)

 

TGH/USF PROSPECTIVE INVESTIGATOR INITIATED STUDY

REQUIREMENTS FOR INFORMED CONSENT FORM (FDA: 21 CFR 50.25, DHHS: 45 CFR 46.116)

 USF TEMPLATE FOR BIOMEDICAL CONSENT FORM AVAILABLE HERE (need to include TGH Injury and HIPAA Language below)

ICF:

  • Tampa General Hospital has specific language that must be included in all research informed consent forms for studies taking place at the hospital. The required injury and HIPAA language should be included in all Informed Consent documents.
  • Must be obtained from the subject or subject’s legally authorized rep
  •  Process must allow sufficient opportunity to consider whether or not to participate
  •  Process must minimize the possibility of coercion or undue influence
  •  Must be in a language understandable to the subject or representative
  •  Must not waive or appear to waive any of the subject’s legal rights
  •  Must not release or appear to release the investigator, sponsor, institution, or itsagents from liability for negligence

Basic Elements of ICF

  1. State that study involves research
  2. Explain purpose
  3. Expected duration
  4. Describe procedures
  5. Identify procedures which are experimental
  6. Describe foreseeable risks
  7. Describe benefits
  8. Disclose alternatives
  9. Describe extent to which confidentiality will be maintained
  10. If more than minimal risk, explain what compensation or treatments are available ifinjury occurs
  11. Whom to contact for questions aboutThe research
  12. The subject’s rights if research-related injury occurs
  13. Statements that: Participation is voluntary, Refusal to participate will not result in any penalty or loss of benefits Subject may withdraw at any time without penalty or loss of benefits
  14. Statement that procedure may involve unforeseeable risks
  15. Reasons participation may be stopped by the investigator without the subject’s consent
  16. Additional costs for participation
  17. Consequences of subject’s withdrawal and procedures for orderly termination
  18. Statement that significant new findings which relate to the subject’s willingness to participate will be provided
  19. Approximate number of subjects

Other USF Consent Form Templates

PROSPECTIVE STUDY PROTOCOL TEMPLATE FOR CLINICAL TRIALS

Study Protocol Title:Be consistent with the Title through out your application, protocol and all the regulatory documents

Table of Contents:

List of Abbreviations:

Use commonly used abbreviations and acronyms.

Principal Investigator, Research Team, and Study Site:Principal investigator: Co-Investigators:Research team and contact Information: Study site:

Research Synopsis Study Title Enter the full title Clinical Phase

Phase I, II, III, or IV (if applicable)

IND Sponsor

Name of IND Sponsor (if applicable)

Study Population Include a brief description of the population such as health/disease status, gender, age, etc.

Study Design Present an overview of the study design for example, randomized controlled trial, or double blinded, crossover or parallel study etc
Sample Size Include total number of patients for the study including other sites. Include sample size plus an estimate for screen failures.

Study Duration Length of time to enroll human subjects in the study till the completion of the study

Study Agent and Intervention Description (If applicable) Include name, dose, frequency, and route of administration, if applicable

Primary Objective Include primary objective and outcome measures

Secondary Objectives Include secondary objectives, outcome measures

Background and Significance: This section is based on your research question. How would you answer the questions and give explanations to your answer? What are the assumptions and relationships?
Justification of your conducting this study based on existing knowledge and your research question. 

Describe the disease including incidence
Description of the Study drug/intervention
Provide summary of previous pre-clinical studies, relevant clinical studies
Include references with citations from the literature.
In the last paragraph state the main purpose of the study summarizing all the information provided in your background section

Objectives: These should be written after the theoretical framework has been developed. The objectives are the intellectual activities that the investigator will perform throughout the research process. Primary Objective
Include the details of your primary objective (which is your main purpose of performing this study and should be focused on one question), outcome measures and method by which outcomes will be determined.

Sample Text: To evaluate the efficacy of antibiotics in the treatment of acute bronchitis

Secondary Objectives
Include secondary objectives which can be two or three can be dependent or independent of the primary objective, outcome measures and method by which secondary outcomes will be determined. To assess patients overall change in symptoms and return to daily activities after 2 weeks of antibiotic treatment
To evaluate management and treatment factors as potential predictors of outcome.
Study design/methodology:
Include the description of study type (double-blinded, placebo-controlled, open/off label, parallel or crossover design, randomized), number of study arms, prospective, retrospective, or observational, survey, or questionnaire
Type of study and design should be decided on the basis of proposed objectives and the availability of the resources.
The methodology explains the procedures that will be used to achieve the objectives. In this section detail of the variables and the ways to measure them should be included.Example text: This is a randomized, double blind study of ….. for the treatment of ….in this patient population
How are you planning to do this study? Details of the methods and procedures should be included

What kind of data will you be collecting to measure your primary and secondary outcomes? What type of randomization method will be used?

Study Population:
Details of the population to be included in the study

Inclusion /Exclusion Criteria

Sample text inclusion criteria:
Confirmed cases of the disease…….
Treated at ——Hospital between —year and—– year
Women of childbearing potential may not be routinely excluded from participating in research, however, pregnant women should be excluded unless there is a clear justification to include them.
Include enrollment of subjects with diverse racial and ethnic backgrounds to ensure an equitable selection.

Study drug /Interventions:
Formulation, packaging, and labeling of the study drug
Address issues with the study drug storage and stability
Provide details of the preparation, administration, and dosage of study drug/intervention)

Study Schedule:
Include a projected start date.
Provide the total length of time participants will remain in the study or will be taking drug including the follow up period. Include an approximate end date of the study.
It is convenient for the reviewer to see the events of the study schedule or duration in the form of a flow chart. Include screening, enrollment, active dosing phase, follow-up visits, and final study visit.

Adverse Event Reporting:
Provide a definition of an Adverse Event (AEs) and Serious Adverse Event (SAEs) based on the study.
Include methods and timings for assessing, recording, and managing adverse events and safety parameters

Also include how will you report these procedures and stopping rules for a study participant?

Statistical Analysis Plan:

What do you plan to analyze from the data you collect? Consult a biostatistician before you finalize your protocol.
Sample size determination
What sample size will you be able to get and if your suggested samples size has enough of power to deliver the significant results? Include the number of subjects you are planning to enroll. For multi-center studies, include the total number of sites expected and the total number of subjects to be enrolled across all sites.

Provide the rationale for the sample size, the calculations on the power of the trial and the clinical justification.
Include plan of accounting for missing, unused and spurious data

Informed Consent Process:

Provide information about the regulatory requirements of the consent form and which languages will be used. For Spanish speaking population a Spanish consent form should be included. The language and writing of an informed consent is usually at a 6th grade level. Include a justification if potentially vulnerable subjects will be enrolled in the study for example pregnant and lactating women, children, prisoners, cognitively impaired and critically ill subjects.

Privacy and confidentiality:
Sample language: Human subject’s names will be kept on a password protected database, and will be linked only with a study identification number for this research. There are no patient identifiers. All data will be entered into a computer that is password protected. Data will be stored in a locked office of the investigators and usually maintained for a minimum of three years after the completion of the study.
Some institutions have different time frame for the storage of data. Check institutional SOPs Risk/Benefit:

Risk to participants:
Identify any risks involved while conducting the study

Benefits to Participants

Include any benefits to the participant or to the overall research field
Sample text: This study does not present the prospect of direct benefit to the participants. However the study does provide an opportunity to gain a better understanding of…

Study Timeline:
Briefly state the stages of your study for example,
Stage 1, screening, enrollment, —-4-6 months
Stage 2, treatment phase
Stage 3, data collection and data analysis
Stage 4, presentation and publication…
Data Safety Monitoring:
Monitoring is an ongoing review of the study throughout its duration.
Any action resulting in a temporary or permanent suspension or delay of the study should be reported to the IRB and to the Office of Clinical Research
The PI is responsible for reporting any reasons outside the planned study design such as incompliance with the protocol or if there is any delay in the initiation of the study due to administrative reasons. .
Plans for collecting data and protocol compliance should be included
Conflict of Interest:
Clearly document any consultative relationship that the principal or co-investigators has with a non-USF entity related to the protocol that might be considered a conflict of interest. Depending upon the type of conflicts, these can be managed accordingly. Consult USF COI committee.

Publication and Presentation Plans:
List any meetings or conferences where you will be presenting the data and the results of your study.
References:
List all the references used in the back ground section at the end of the protocol.
Endnote and reference Manager are the software tools for publishing and managing bibliographies and are used frequently for citations and managing your own libraries.

TGH PROSPECTIVE STUDY & FEASIBILITY APPLICATION (AFTER PROTOCOL CREATION AND IRB APPROVAL)

 

 

 

OTHER IMPORTANT DOCUMENTS

TGH Financial Disclosure Form
Patient Consent Checklist – Include In Study File for Each Enrolled Patient
USF Health Investigator Initiated Site and Forms