Investigator Resources
Below are templates of commonly needed submission documents. It is recommended to use templates that incorporate regulatory required elements.
Training: IRB Submissions made easy
IRB Templates
- 600.01 - Protocol Template (docx)
- 600.01 - Retrospective Data Review Protocol Template (docx)
- 600.02 - Quality Improvement Project Template (docx)
- 600.02 - Teaching Research Methods - Student Project Verification Template (docx)
- 600.02 - Course Project Description Template (docx)
- 600.02 - Procedures for Use of Honest Broker Template (docx)
- TAMU-CC Survey Study Recruitment Flyer Template (ppt)
- TAMU-CC Facebook Recruitment Page Template (ppt)
- TAMU-CC Survey Study Recruitment Postcard Template (ppt)
- TAMU-CC Interview Study Recruitment Flyer Template (ppt)
- 800.01 - Investigator Recruitment Plan Worksheet (docx)
- 800.01 - Flyer for Study Advertisement Template (docx)
- 800.01 - Not Study Specific Advertisement Template (docx)
- 800.01 - Survey Study Advertisement Template (docx)
- 800.01 - Dear Subject Letter Template (docx)
- 800.01 - Facebook Recruitment Script Template (docx)
- 800.01 - Classroom Recruitment Script Template (docx)
- 800.01 - Letter of Support for Non-TAMU-CC Sites Template (docx)
- TAMU-CC Information Sheet for Survey Studies Template (ppt)
- TAMU-CC Interview Consent Form Template (ppt)
- TAMU-CC Focus Group Consent - Informational Flyer Template (ppt)
- 1200.02 - Information Sheet for Exempt Studies Template (docx)
- 1200.02 - Information Sheet for Non-Exempt Studies Template (docx)
- 1200.02 - Tiered Informed Consent - Social Behavioral Template (docx)
- 1200.02 - Tiered Informed Consent - Interventional Template (docx)
- 1200.02 - Short Form Template (docx)
- 1200.02 - Broad Consent For Future Research Template (docx)
- 1200.02 - Parent Permission and Minor Assent Consent Template (docx)
- Adult Addendum When Subject Turns 18 Consent Template (docx)
- 1200.07 - Telephone Consent Script - Adult Subjects Worksheet (docx)
- 1200.04 - Informed Consent Process Worksheet (docx)
- 1100.09 - Consenting Non-English Speaking Persons Worksheet (docx)
- 1100.09 - Translation Certification Form (docx)
- 1100.10 - Capacity to Consent Worksheet (docx)
- Parental Permission and Child Assent - Research Study Participation Form Template (docx)
What is a research repository?
A research repository is defined as a collection of data/biospecimens that have been collected and stored with the intention of using the materials for future research, either by the investigator who collected them or by sharing the materials with other investigators.
Researchers interact with a repository in 3 different ways:
- Primary collection or aggregation of data and/or biospecimens
- Intake, storage, maintenance, and distribution of repository data and/or biospecimens
- Secondary use or analysis of data and/or biospecimens obtained from a repository
When do I need to create a repository?
When you plan to retain collected data and/or biospecimens for future research.
How do I create a repository?
- Start an IRB application in iRIS.
- Draft a repository protocol and the needed documents to manage the repository.
Find more information and templates for repositories in the Microsoft Teams channel: IRB Investigator Forum - Research Repository
Forms:
Repository Process: Primary Collection
- Recruitment Method
- Repository Workflow for Primary Collection - Direct Recruitment Method (vsdx)
- Broad Consent to Participate in a Research Repository Form (docx)
Recruitment Method: Through Collaborating Investigators
- Repository Workflow for Participant Recruitment and Consent - Indirect Method via Active Researchers (vsdx)
- Active Researchers Recruitment Letter Template (docx)
- Repository Consent Form - Future Use Provision Within Study Template (docx)
Repository Process: Intake and Storage
RepositoryTemplateParticipant Withdraw DataDictionary
- A project template to manage this process in REDCap has been created (Template Repository - Participant Withdraw).
- Get a copy of the repository form request in REDCap:
- Request REDCap access through the IT Service Desk
- IT Point of Contact for REDCap:
- Denise Dougherty, denise.dougherty@tamucc.edu
- Once you have a REDCap username, email Michelle Eisenman to get a copy of the Repository Template - Study Access Request to your REDCap account.
- Build your own form: Repository - Participant Withdraw Template (csv)
Repository Process: Distribution and Secondary Use
REDCap Project Template: Repository Template - Study Access Request
- A project template to manage this process in REDCap has been created (Template Repository - Study Access Request).
- Get a copy of the repository form request in REDCap:
- Request REDCap access through the IT Service Desk
- IT Point of Contact for REDCap:
- Denise Dougherty, denise.dougherty@tamucc.edu
- Once you have a REDCap username, email Michelle Eisenman to get a copy of the Repository Template - Study Access Request to your REDCap account.
- Build your own form: Repository - Study Access Request Template (csv)