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
PowerPoint Templates
800.01 Worksheet, Investigator Recruitment Plan
800.01 Template, Advertisement - Flyer for Study
800.01 Template, Advertisement - Not Study Specific
800.01 Template, Advertisement - Survey Study
800.01 Template, Dear Subject Letter
800.01 Template, Facebook Recruitment Script
PowerPoint Templates
1200.02 Template, Information Sheet for Exempt Studies
1200.02 Template, Information Sheet for Non-Exempt Studies
1200.02 Tiered Informed Consent Template - Social Behavioral
1200.02 Tiered Informed Consent Template - Interventional
1200.02 Broad Consent For Future Research Template
1200.02 Consent Template, Parent Permission and Minor Assent
Consent Template, Adult Addendum When Subject Turns 18
1200.07 Worksheet, Telephone Consent Script - Adult Subjects
1200.04 Worksheet, Informed Consent Process
1100.09 Worksheet, Consenting Non-English Speaking Persons
1100.09 Form, Translation Certification
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/aggregation of data/biospecimens
- Intake, storage, maintenance, and distribution of repository data/biospecimens
- Secondary use/analysis of data/biospecimens obtained from a repository
When do I need to create a repository?
When you plan to keep data/biospecimens collected for future research.
How do I create a repository?
- Start an IRB application in iRIS.
- Draft a repository protocol and needed documents to manage the repository.
Find more information and templates for repositories in the Teams channel: IRB-Investigator Forum/Research Repository
Forms:
Template, Recruitment Repository Protocol.docx
Repository Process: Primary Collection
Workflow.Primary Collection.Recruitment Method.Direct to Repository.vsdx
Template.Repository broad consent.docx
Recruitment Method: Through Collaborating Investigators
Template.Active Researchers Recruitment Letter.docx
Template Repository consent.Future use Provision within study consent.docx
Repository Process: Intake and Storage
Workflow.Subject Withdraw Process.vsdx
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 from IT. request for Redcap access through the IT service desk portal: https://www.tamucc.edu/information-technology/contact-us.php
- IT point of contact for REDCap: Denise Dougherty, denise.dougherty@tamucc.edu.
- Once you have a REDCap username, email Michelle Eisenmann or Rebecca Ballard to get a copy of the Repository Template - Study Access Request to your REDCap account.
- Build your own form: RepositoryTemplateParticipant Withdraw DataDictionary.csv
Repository Process: Distribution and Secondary Use
Workflow.2ndUseResearcher.vsdx
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 from IT. request for Redcap access through the IT service desk portal: https://www.tamucc.edu/information-technology/contact-us.php
- IT point of contact for REDCap: Denise Dougherty, denise.dougherty@tamucc.edu.
- Once you have a REDCap username, email Michelle Eisenmann or Rebecca Ballard to get a copy of the Repository Template - Study Access Request to your REDCap account.
- Build your own form: RepositoryTemplateStudyAccessR_DataDictionary_2023-08-14.csv