Ancillary Studies

Ancillary Studies Proposal

Title of Study:


Principal 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






Outcome of ALF/ALI






Specimen type





















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


Sera (#, mL)

Plasma (#, mL)


(#, μg)


(#, 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:








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