Applications, Forms & Supporting Documents

Applications

1. New Mandatory Cover Form:

 (Only for submissions by a Faculty) Not applicable for student projects

 

2. IRB Applications:

The following is a list of Initial Applications, 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)

Version 11. March 2017
Initial Protocol Application – Social and Behavioral Research 
(For all research projects that require Full or Expedited review)
Version 6. March 2017
Protocol Exempt Application 
(For all research projects that fall under an Exempt review)
Version 11. March 2017
Supplemental Sheet - Study Personnel Version 4. April 2014
Classroom Project Application
(For student projects in Research Methodology Courses)
Version 5. November 2016
LAU Medical Center-Rizk Hospital Signature Page 
(This page should accompany any of the above applications if the research project is to be conducted at LAU Medical Center-Rizk Hospital)
Version 4. March 2017
   

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

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)
Version 6. October 2016
Protocol Amendment Application
(For all research projects where the PI intends to amend the protocol,
informed consent, any change to the research project procedures)
Version 6. October 2016
Request for Protocol Closure Form
(For all research projects that have completed, closed, suspended or terminated)
Version 6. October 2016


Reporting Forms

Investigator Financial Disclosure Form Version 4. April 2014
Adverse Event Reporting Form
(For Adverse Events occurring at the site)
Version 1. November 2016

Supporting Guidance Documents and Templates

Informed Consent Template
(Minimal Risk Studies) - English
Version April 2017
Informed Consent Template
(Minimal Risk Studies) - Arabic
Version April 2017
Informed Consent Addendum Version November 2016
Parental Consent (English)
Version May 2015
Parental Consent (Arabic) Version February 2017
Child Assent (English) Version May 2015
Child Assent (Arabic) Version February 2017
Research Protocol Template Version January 2017
Glossary - Medical Lay Terminology Version November 2011
Glossary - Clinical Trials Terminology Version 2. Applied Clinical Trials Magazine Online
Letter to companies, Schools, centers, etc. (Template signature page) Version February 2017
Sample introduction to surveys and questionnaires - English and Arabic Version April 2017
Delegation of Responsibility – Study Personnel Version November 2016
Advertisement Template for Research Version November 2016