Ancillary Studies Proposal

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):

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:






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