Applications, Forms & Supporting Documents

Signature pages and IRB Applications

1. New Mandatory Automated Cover Form (RPSF) and Signature Pages, as applicable:

      a. Research Proposal Submission Form (RPSF)

       This form is only required for submissions by a Faculty: Not applicable for student
        projects. 
      
 This form includes an option if the study is to be conducted at LAUMCRH

        b. Other required Signature Pages, as applicable

        c. Adding LAUMCRH  as a research site after you have secured LAU IRB approval,
            please use the following form 

2. IRB Applications:

ONLY One application should be submitted depending on the type of submission for review

Initial Protocol Application - Biomedical Research  
(For all research projects that require Full or Expedited review)

Initial Protocol Application – Social and Behavioral Research 
(For all research projects that require Full or Expedited review)
Protocol Exempt Application 
(For all research projects that fall under an Exempt review)
Supplemental Sheet - Study Personnel
Classroom Project Application
(For student projects in Research Methodology Courses)
 

Other required applications, as applicable and required, during the course of the Research Project and after Initial review and approval: 

Addition of Research Personnel to an already IRB Approved research study
Continuing Review Application
(For all research projects that have been approved under Full or Expedited review and requires renewal to continue past expiry date noted in the Approval letter)
Protocol Amendment Application
(For all research projects where the PI intends to amend the protocol,
informed consent, any change to the research project procedures)
Request for Protocol Closure Form
(For all research projects that have completed, closed, suspended or terminated)


Reporting Forms

Investigator Financial Disclosure Form
SAE/ Non-SAE Unexpected and Related Reporting Form
(For Adverse Events occurring at the site)

Supporting Guidance Documents and Templates

 

1.    Informed Consent Templates

Please customize the informed consent document below relevant to you targeted population and research project

  *  Introductory Informed consent to surveys, questionnaires or interviews (English)
  *  Introductory Informed consent to surveys, questionnaires or interviews (Arabic)
  *  Informed Consent Template for Minimal Risk Studies (English)
  *  Informed Consent Template for Minimal Risk Studies (Arabic
  *  Informed Consent Addendum in the event new information arose after initial consent
  *  Informed Consent Addendum in the event new information arose after initial consent (Arabic)
  * Parental Consent Form Less then Minimal Risk (English)
  * Parental Consent Form Less then Minimal Risk (Arabic)
2.    Research Protocol Template
3.    Glossary - Medical Lay Terminology
4.    Glossary - Clinical Trials Terminology
5.    Letter to companies, Schools, centers, etc. (Template signature page to secure the necessary approval)
6.   Letter to companies, Schools, centers, etc. (Template signature page to secure the necessary approval) (Arabic)
7.    Delegation of Responsibility – Study Personnel
8.    Advertisement Template for Research