Transcript MSCR Instructional Presentation

TVDC Milestone Completion
Reports
Barbara Griffith, M.S
TVDC Project Director
4/21/2008
MS Completion Reports
(MSCR): Purpose
• “Stand Alone” Report for the Milestone
• Summarize the Milestone’s objectives,
methods, original data, interpretations and
significance
• Equivalent to a mini-manuscript and could be
developed into an article for publication
• Required by the TVD Contract
• Make monthly technical reports virtually
obsolete, though the monthly technical reports
will be saved for reference.
MS Completion Report
Template: Content
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Signature Page (Cover)
Abstract/Executive Summary (Section 1)
Milestone Objectives (Section 2)
Methods, Critical Reagents and SOPs
(Section 3)
• Salient Original Data, Results,
Interpretation, Quality Control (Section 4)
• Deliverables Completed (Section 5)
• Appendices (Section 6)
Abstract/Executive Summary (1)
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Summary= abstract in journal publication
Brief statement of goals
Succinct statement of results
Overall interpretation of data, without
reviewing the data itself
• Concise statement of milestone
significance in the context of the TVDC
contract
Milestone Objectives (2)
• As listed in the Statement of Work and
Monthly Technical Reports for the
milestone
• UNM will pre-fill this text into the Milestone
Completion Report templates
Methods, Critical Reagents and
SOPs (3)
• Methods: summarize and include details
necessary to re-perform critical
experiments
• Critical Reagents: list reagents, sources
and critical lot numbers
• Standard Operating Procedures: protocols
followed in your laboratory written in
quality format ( format presented by Marlene Hammer at the
UNM/DVC/NIAID meeting in Woods Hole 2006; “LVS growth in
Chamberlain’s” is “gold standard” example)
Salient Original Data, Results (4)
• Include only positive and negative data that
contribute to the completion and understanding
of the Milestone. Will be a judgment call.
• Do NOT include all original data from all
experiments performed
• Example: optimizing ASU IVT product synthesis
– Performed pilot studies to test many variables and
to optimize the synthesis : His tags locations, feeds,
template spikes, purification methods, etc.
– Summarize the variables tested in pilot studies,
describe which are significant, and only present
original data on the critical variables that led to
optimal IVT product quality and quantity.
Salient Original Data, Results (4)
• Organize data by the goals or deliverables for
the milestone
• Insert original data into the text to enhance the
flow of the report. Insert data as an appendix if data interrupts
the flow of the report (e.g. multi sheet excel workbooks)
• Provide a figure/table legend to briefly describe
how the experiment was performed (similar to a figure
in a publication)
• Annotate tables and figures with notebook
locations and electronic locations. Provide a crossreference if the final locations differ from locations cited in the Monthly
Technical Reports
• Include QC that supports conclusions (e.g. DNA
sequence verification, experiment reproducibility, protein expression
verification by Western blot)
Data Interpretation and
Quality Control (4)
• Interpretation
– Provide interpretation of data and results
– Address unresolved questions, issues or problems relevant to
the milestone
– Articulate possible next steps to advance the understanding of
the data and results
• Quality Control
– Include QC data that supports the repeatability of
the data (e.g. number of times that experiments were repeated,
statistical analysis of variance, replicates
– Include QC data and information that supports the
interpretation and significance of the results
• (e.g. DNA sequence verification, experiment reproducibility,
protein expression verification by Western blot)
Deliverables Completed (5)
• Review deliverables stated in the SOW from the
subcontract. (e.g. reagents, SOPs, MS Completion Reports)
• Reagents Generated
– Types: bacterial strains, plasmid constructs,
polypeptides, RNA/DNA, tissues
– type, name, # of vials, concentration, storage media,
storage location at subcontractor’s institution, protein
or DNA sequence, etc
• Reagents Shared with UNM and other
Subcontractors:
– Date, quantity, institution, location at institution
Appendices (6)
1. List of Original Data Tables & Figuresquick reference guide to original data locations
2. Milestone Completion Report
Assessment Criteria (from Strategic Work Plan)tracks review of reports
3. Original Data- if too disruptive to flow of the MS
Completion Report
4. SOPs- procedures written in quality format
MS Completion Reports: Status
• Subcontractors have two versions of MS Completion
Report Templates
– Instructional (sections describe text to add to each section)
– Template (sections are blank for adding text from subcontractors)
• Completed Milestones
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Cerus: 40
ASU- 25, 32, 33, 34,
UTSA- 16, 39,43, 48, 51
LBERI- None
UNM- None
• Terminated Milestones:
– Cerus: 41,42,43,44,45,46, 47
MS Completion Reports: Status
4/21/08
•
Completed Milestones:
– Cerus: 40 (no drafts to UNM; draft due 6/1/08)
– ASU- 25 (5 drafts exchanged 10/23/07, 11/14/07, 12/21/07, 3/31/08,
4/18/08) plus 4 SOPs
– ASU- 32 (6 drafts exchanged 12/06, 10/23/07, 11/16/07, 11/20/07,
11/30/07, 12/21/07 to NIAID, 3/6/07, 4/8/08) plus 2 SOPs and 7
appendix files
– ASU- 33 No draft to UNM, but 10 SOPs rec’d 3/31/08
– ASU- 34 No draft to UNM
– UTSA- 16 (6 drafts exchanged 12/06, 2/1/07, 11/2/07, 12/3/07, 4/4/08
4/7/08) plus 3 SOPs (ready for NIAID once SOP#3 is finalized)
SOP#1&#2 are approved by UNM)
– UTSA- 39 (5 drafts exchanged 10/23/07, 11/02/07, 2/11/08, 4/4/08,
4/7/08) plus 2 SOPs; Sent to NIAID 4/7/08
– UTSA- 43 (1 draft exchanged 2/25/08) plus 1 SOP
– UTSA- 48 (5 drafts exchanged 3/20/07, 11/2/07, 2/11/08, 4/4/08,
4/7/08)
– UTSA- 51 No drafts to UNM
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MS Completion Reports: Status
4/21/08
• Terminated Milestones: Cerus
– 41(85% completed), will write termination report
– 42 (25% completed), will write termination report
– 43 (0% completed) no completion report
– 44 (5% completed), will write termination report
– 45 (0% completed), no completion report
– 46 (53% completed), will write termination report
– 47 (0% completed), no completion report
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MS Completion Reports:
Recurrent Problems
4/21/08
• Combining results (section 4) into methods (section 3)-is acceptable if
enhances flow of multi-step method with intermediary results, that
leads to a final result
• Critical reagents list missing in methods (section 3)
• Original Data missing (section 4)
• Figure Legends missing; data locations missing (section 4)
• SOPs not provided and not listed in table (section 3)
• SOPs not in quality format- sections missing, spinning w/o rpm and
centrifuge, “immediate” usage not defined in time units
• Appendix 1: electronic file location missing or too general to allow
tracking (e.g. Susies’ files on laptop)
• Providing incomplete literature citations (section 6)
• Incomplete information, relative to UNM requests in the MSCR
template or UNM requests with first review
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Goal: Expedite MSCR completion
• Reduce number of review rounds
• Authors: follow instructions and call UNM
with questions
• 1st round review: electronic exchange of
MSCR and SOPs with UNM requested
edits
• 2nd round review: UNM will call author to
discuss MSCR and SOP edits
• Complete well and provide to NIAID
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