Proposal for Module 3 of MIATA Version 1.0 ((based on Consensus workshop and comments from the public consultation period)

Purpose: Reporting framework for publications of human immune monitoring T cell studies  

Module 3: Data acquisition

Proposal for Version 1.0, Submodule 3A: Equipment and Software  

Required to report:

• Description of equipment and software versions used for data acquisition

Optional:

• Investigators might want to provide information on the routine QC procedure(s) whenever it enables better understanding of the experiment.

Excluded:

• Information on instrument validation will be covered in Module 5 (Lab environment)
• Information on setup of the equipment and operator training

Version 0: Module 3B: Controls Applied

Proposal for Version 1.0, Submodule 3B: Control Applied 

General:  Rename Sub-module: Acquisition strategy

Required to report:

• Display of representative raw data (e.g. FACS plots or ELISpot photos) including negative control and positive response example

Optional:

• Investigators might want provide a more detailed explanation on their gating strategy whenever it enables better understanding of the experiment. In case an uncommon strategy was applied comment on why the specific strategy was chosen.
• Investigators might want to provide information on instrument settings, method and reagents applied for compensation whenever it enables better understanding of the experiment. 
• A statement should be given about the review process of raw data for data consistency and plausibility.

General comment: The reporting of representative data sets was also discussed in module 4. It was decided to leave this requirement in module 3.

Proposal for Version 1.0, Submodule 3C: Quality Assurance  

Required to report: Nothing

General: This sub-module should be removed. The auditing option is being addressed in sub-module 3B. All other QA aspects are covered in module 5.

The following colleagues participated in the revision of Module 3 during the Webinar on Monday, May 17^th 2010.

Michael Kalos, Simone Joosten, Sacha Gnjatic, Lisa Butterfield, Evelyna Derhovanessian, Jill O’Donnell Tormey, Jianda Juan, Guido Ferrari, Sjoerd van der Burg, Cecile Gouttefangeas, Kunle Odunsi, Cedrik Britten and Sylvia Janetzki