Ancillary Studies Proposal

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