Title of Study:

Principal Investigator(s):

Institution:

Co-Investigator(s):

ALFSG Co-Investigator(s):

Persons providing statistical support:

Will this study require prospective collection of data?  Yes     No  

Project Description

Purpose of study:

Primary hypothesis:

Briefly describe the scientific rationale for the study:

Briefly describe the investigators’ qualifications including previous experience in this area:

Type of data and/or specimens requested: 

Specimen Chart (complete sections relevant to this proposal) #1

Specimen Chart #2

*If available

Identify categories of subjects:

Number of required subjects & samples per category: 

Human Subject Considerations (including ethical and consent considerations, if applicable):

Data Collection, Analysis and Management 

Define study outcomes:

Where will study data be stored?

Qualifications of person(s) providing statistical support:

Describe the statistical and clinical basis for the sample size calculation:

Briefly describe the study design and indicate, in general terms, how the design will fulfill the intent of the study:

REFERENCES:

Financial Considerations

Funding source/sponsor(s):      Grant       Corporate Sponsor       Internal

Name of sponsor:

Are additional resources required to complete the project that are not currently available?     

Yes      No

If Yes, please describe:

Total estimated cost of project (direct + indirect):

Do you or any member of the study group have a financial conflict of interest with this protocol? 

Yes    No  

I have read and agree to the ALFSG publications policy as outlined in the ALFSG Publications Policy.

I understand that the ALFSG is not responsible for funding or statistical support for this project.

Name:      ____________________________________

Date:      /20