Ancillary Studies

Ancillary Studies Proposal

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 Type 1

Specimen Type 2

Specimen Type 3

Specimen Type 4

Severity of liver injury

ALF and/or ALI

 

 

 

 

Etiology of ALF/ALI

Specify

 

 

 

 

Outcome of ALF/ALI

Specify

 

 

 

 

Specimen type

Sera

 

 

 

 

Plasma

 

 

 

 

DNA

 

 

 

 

Urine

 

 

 

 

Liver Tissue

 

 

 

 

Specimen date(s)

Options: Days 1-7, 1 yr, 2 yrs (keep as broad as possible)

 

 

 

 

Amount per specimen

#

 

 

 

 

Number of specimens

#

 

 

 

 

 

Specimen Chart #2

Visit

Sera (#, mL)

Plasma (#, mL)

DNA

(#, μg)

Urine

(#, mL)

Liver biopsy slides (#, #slides)

Liver tissue from explant (#, #slides)

Day 1

 

 

 

 

 

 

Day 2*

 

 

 

 

 

 

Day 3*

 

 

 

 

 

 

Day 4*

 

 

 

 

 

 

Day 5*

 

 

 

 

 

 

Day 6*

 

 

 

 

 

 

Day 7*

 

 

 

 

 

 

Additional blood or tissue*

 

 

 

 

 

 

One year*

 

 

 

 

 

 

Two years*

 

 

 

 

 

 

*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