THE UNIVERSITY OF JORDAN JORDAN UNIVERSITY HOSPITAL PROTOCOL FOR

HRATCH PAPAZIAN 8TH EGYPTOLOGICAL TEMPELTAGUNG – WARSAW UNIVERSITY OF
Calisia Universitykalisz Poland Nowy Świat 4 62800 Kalisz
CHARLES UNIVERSITY OF PRAGUE FACULTY OF SCIENCE

DUGHUG CONFERENCE 6TH 8TH JULY 2005 EXETER UNIVERSITY
EARTHQUAKE ENGINEERING RESEARCH INSTITUTE OREGON STATE UNIVERSITY
EDUCATION 998504 DMA MUSIC COMPOSITION CORNELL UNIVERSITY DISSERTATION

PROTOCOL FOR RESEARCH STUDY INVOLVING HUMAN SUBJECTS

The University of Jordan

Jordan University Hospital

PROTOCOL FOR RESEARCH STUDY INVOLVING HUMAN SUBJECTS

[Insert title of study here]

[Insert name of principal investigator here]

Required documents

CV of applicant or principal investigator
Proof of funding (if any)
Grant application (if any)
Informed consent form
Questionnaire (if any)
Certificate of Protecting Human Subject Research Participants online training

^* All members of the research team including the PI must go through the online training for Protecting Human Subject Research Participants provided by the National Institutes of Health (https://phrp.nihtraining.com/). and present a copy of the certificate.

Research Team

Name of PI:

Affiliation:

Address in full:

Phone number (work/extension): Phone number (mobile):

E-mail (1): Email (2):

Signature:

Research team^*

Name	Affiliation	Telephone	E-mail	Role	Signature

^* All members of the research team including the PI must go through the online training for Protecting Human Subject Research Participants provided by the National Institutes of Health (https://phrp.nihtraining.com/). and present a copy of the certificate.

Synopsis

Title
Principal Investigator
Objectives	As stated inside
Test facility(ies)	Where will the research be conducted at?
Duration of study	As stated inside
Source(s) and amount of funding
Subjects (type and number)
Sample Collection	\|Examples: Blood, serum, tissue, etc. Questionnaire
Test Article	Examples: Biomarker, DNA, etc.
Risk assessment	 None or minimal  Intermediate  High

Table of Contents

Contents	Page No.
Title page………………………………………………………………………………..		1
Research team……………………………………………………………………….		2
Synopsis……………………………………………………………………………..
Table of contents…………………………………………………………………….
List of abbreviations………………………………………………………………
Background and significance………………………………………………..
Specific Aims……………………………………………………………….
Study Ethics…………………………………………………………………
Subjects……………………………………………………………………..
Subject Recruitment and Screening……………………………………………
Inclusion criteria………………………………………………………………
Exclusion criteria………………………………………………………………
Tests and samples…………………………………………………………
Data……………………………………………………………………..
Analysis……………………………………………………………………..
Duration of study……………………………………………………………
References…………………………………………………………………
Appendix A. Informed consent……………………………………………………
Appendix B. Questionnaire………………………………………………………

Abbreviations

Abbreviation	Full name

Background and significance (750-1000 words):

Provide a brief summary of the field of study, a short description of the study, and its clinical significance. Describe why it makes sense to conduct the study in the study population and why the information is needed.

Objectives

State all OBJECTIVEs (as numbered or bullet points).

Study Ethics:

State how the study will be conducted under the Helsinki Declaration-Ethical Principles for Medical Research Involving Human Subjects (please read the guidelines at http://www.wma.net/en/30publications/10policies/b3/). Important points to consider include:

Existence of a signed informed consent that describes the nature of the study, contact information, freedom to withdraw, protection of privacy and confidentiality. This form must be submitted as an appendix.
Freedom to withdraw. A subject may withdraw from the study at any time if the subject, the investigator, or the Sponsor feels that it is not in the subject’s best interest to continue. All subjects are free to withdraw from participation at any time, for any reason, specified or unspecified, and without prejudice.
The existence of measures to a coding system for samples and information.
Information about study subjects will be kept confidential. The subject must be informed what information will be collected from subjects in this study, who will have access to that information, and who will use or disclose that information.

Subjects:

Subject Recruitment and Screening

Describe how subjects will be recruited for the study. State the number of subjects. What is the statistical rationale for the number of subjects?

Inclusion Criteria

Create a numbered list of criteria subjects must meet to be eligible for study enrollment (e.g. age, gender, target disease, concomitant disease if required, etc.). Typically, this list should include items such as: “subjects capable of giving informed consent”, or if appropriate, “subjects who have an acceptable surrogate capable of giving consent on behalf of the subject.” State criteria for both control subjects as well as targeted subjects.

Exclusion Criteria

Create a numbered list of criteria that would exclude a subject from study enrollment (e.g. age, gender, target disease, concomitant disease if required, etc.). Typically, this list should include items such as: “subjects incapable of giving informed consent”. State criteria for both control subjects as well as targeted subjects.

Tests and samples:

Will any type of samples be collected or withdrawn from the study subject? How will these samples be handled and coded? Are these data additional to the routinely tests requested by the clinician? If not, who will handle the charges of the requested tests?

Data:

What type of data will be collected from the study subject? Will any diagnostic data be collected such as chemistry profile, radiology reports, etc.?

The Investigator must prepare a form to collect and maintain adequately and accurately pertinent data for each subject. This form must be submitted as an appendix.

Taking into consideration that information about study subjects must be kept confidential. The subject must be informed of the following:

What information will be collected from subjects in this study

Who will have access to that information and why

Who will use or disclose that information

Will data be coded? Will names of subjects be known? How will data be stored and handled?

Analysis:

A statistical analysis plan describing the analyses that will be performed must be thought of and provided.

Duration of the study:

The duration of the study must be provided in months.

References:

List all references here preferably alphabetically order by last name

Appendices

Attach appendixes such as informed consent, data collection form, and others.

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