Labs and Liver Subgroup Minutes

18Oct2011

Labs / Liver Subgroup

Academia/FDA/Industry Safety Graphics Working Group _______________________________________________________________________

• Discuss next steps for the team

• The current status of the Wiki environment was discussed including the following:
  • The Labs/Liver Subgroup has been able to upload thumbnails of all graphs to the Wiki and hyperlink these thumbnails to the blank graph form
  • 6 of the 26 graphs are finalized on the Wiki and include the thumbnail, final image, code and all information filled in on the form template
  • Tentatively we have approximately 11/12 of the remaining graphs being finalized by the team members and possible external contributors
  • The Wiki will be explored in detail at the next large group meeting to ensure that we are on the right path
• For graphs that came from vendors, we need to decide if we are going to pursue the authors for their code or if we are going to program code internally based upon the image. The resolution was to discuss at the next working group meeting.
• The top 5 chosen graphics (as chosen by the subteam members) were displayed at the recent face:face meeting with the larger group.

• The team discussed the path forward for identifying which graphics will be sent to the larger group for review
• It was decided that the form developed by Mat Soukup will be utilized for each graphic chosen
• The team decided to consolidate the existing clinical questions and align the most appropriate graphics to the questions as an initial set of graphics to include.

• Each team member will review the clinical questions and offer suggestions for consolidation of the questions. Mac will combine the comments and circulate a final version of the consolidated clinical questions to the team.
• Once the team receives the final questions document, each team member will align their choice of appropriate graph(s) to the clinical questions. *Note: The top 5 graphs that were chosen by the team and discussed at the large group face:face meeting need to be included in each members choices.
• Next regularly scheduled meeting will be scheduled within approximately 3 weeks.

14Jun2011

Labs / Liver Subgroup

Academia/FDA/Industry Safety Graphics Working Group

______________________________________________________________________

• Discuss next steps for the team

• To move the process forward, the Labs/Liver sub team will need to focus on the task of creating final graphics with details for inclusion on the wiki site. Mac will circulate those graphics created or supplied by team members to the team member who supplied the graph. Team members will attempt the following:
  • Team members to update one or two individual graphics with comments/suggestions that are included on the power point for the specific graphic
  • Team members to provide a title, raw code (does not need to be coded against the wiki dataset at this point), details etc. for wiki graph form
• The wiki document will not include clinical questions; however the graph form will include the questions. In an effort to consolidate, the current clinical questions will need to be pared down and combined if possible. Mac will circulate a before/after set of clinical questions for review.

• The current status of the Wiki environment was discussed including the following:
  • The Labs/Liver Subgroup has been able to upload thumbnails of all graphs to the Wiki and hyperlink these thumbnails to the blank graph form
  • 6 of the 26 graphs are finalized on the Wiki and include the thumbnail, final image, code and all information filled in on the form template
  • Tentatively we have approximately 11/12 of the remaining graphs being finalized by the team members and possible external contributors
  • The Wiki will be explored in detail at the next large group meeting to ensure that we are on the right path
• For graphs that came from vendors, we need to decide if we are going to pursue the authors for their code or if we are going to program code internally based upon the image. The resolution was to discuss at the next working group meeting.

• Team members to continue to finalize graphs and forward to Mac for inclusion on the Wiki.
• Next regularly scheduled meeting will be scheduled for mid July.

17May2011

Labs / Liver Subgroup

Academia/FDA/Industry Safety Graphics Working Group

________________________________________________________________________

• Discuss next steps for the team

• The topic of a document/template design was discussed. The team decided on utilizing the clinical questions document as a table of contents for a hyperlinked document with thumbnails for the graphics.

• The draft hyperlinked document was shared with the wiki team and it was decided to use the document as a pilot on the wiki. The document will be arranged by each of the 4 categories within our group (Baseline and trending, Association between lab variables, Liver function tests, General). Within each category will exist thumbnails of the graphs included in the section. Although the graphs can span multiple sections, there will be one section in which a graph resides. The user will click on the graph and be taken to the graph form page which will include a link to a full view of the graph as well as in depth information about the graph (author, title, uses, clinical questions answered, details, code etc). More details about the form and format will be part of further discussions with the main group.
• In general, a user to the wiki site will follow these simple steps to search for graphics:
  • Log onto wiki
  • Choose specific graphics section (AE, Labs, ECG)
  • At specific section, click on lab thumbnail of choice
  • User taken to form page with link to full screen graphic, code, details etc.
• To move the process forward, the Labs/Liver sub team will need to focus on the task of creating final graphics with details for inclusion on the wiki site. Mac will circulate those graphics created or supplied by team members to the team member who supplied the graph. Team members will attempt the following:
  • Team members to update one or two individual graphics with comments/suggestions that are included on the power point for the specific graphic
  • Team members to provide a title, raw code (does not need to be coded against the wiki dataset at this point), details etc. for wiki graph form
• The wiki document will not include clinical questions; however the graph form will include the questions. In an effort to consolidate, the current clinical questions will need to be pared down and combined if possible. Mac will circulate a before/after set of clinical questions for review.

• Mac will circulate the graphs to team members.
• Mac to circulate the proposed updated clinical questions.
• Team members to finalize 1 or 2 graphs each for inclusion in the wiki pilot.
• Next regularly scheduled meeting will be scheduled for mid June.

21Apr2011

Labs / Liver Subgroup

Academia/FDA/Industry Safety Graphics Working Group

________________________________________________________________________

• Discuss next steps for the team

• None to report

• The topic of a document/template design was discussed. The team decided on utilizing the clinical questions document as a table of contents for a hyperlinked document with thumbnails for the graphics. Mac circulated a very draft document for review.
• The team decided the best path to move forward with the hyperlinked document would be the following:
  • Roll up the clinical questions into their respective categories
  • Choose the best graphics that represent the categories. Those graphics which are similar should not be included in the hyperlinked document so that there are not too many thumbnails. This would lessen the burden on the end user.
  • Each graphic chosen for inclusion will have a header that explains the clinical question(s) answered and the use of the graphic and a footer which offers other ways to use the existing graph and how to create others using it as a foundation
  • Each graphic will have a hyperlink to code (not to be complete at this point - will be discussed at main group meeting)
  • Mac will circulate a draft within a few weeks and this will be reviewed before/during our next subgroup meeting. Additionally, members of the team will each have a set of graphics to which they will add footnote/header sections.
• There were many questions that need to be brought to the main group meeting, including the following:
  • The team felt that it is very important to have another face to face meeting with the main group, hopefully over the DIA meeting if possible
  • It would be helpful if we knew the approaches the other teams are taking towards a hyperlinked document and as a larger group, choose the most appropriate approach as a standard
  • Overall next steps for the 3 subgroups should be a focus at this point, with consistency across the groups.
  • Best approach to programming the graphics as we are not all experts.
• Programming of the graphics is still a topic, but will first be discussed at the next main group meeting.

• Mac will circulate the draft document to the team.
• Team members to choose a specific graphic to program if possible.
• Next regularly scheduled meeting will tentatively occur on Tuesday the 17^th of May.

23Mar2011

Labs / Liver Subgroup

Academia/FDA/Industry Safety Graphics Working Group

_______________________________________________________________________

• Discuss next steps for the team

• None to report

• The team to share the final graphic recommendations with their clinicians if possible.
• The team discussed the next steps regarding programming and uploading graphics. Each member of the team to look into the possibility of programming one simple graphic over the next two meetings. There exists a CDISC dataset on the wiki.
• The topic of a document/template design was discussed. The team decided on utilizing the clinical questions document as a table of contents or hyperlinked document with thumbnails for the graphics. Mac to create a draft document and circulate to the team.

• Mac will circulate the draft document to the team.
• Team members to choose a specific graphic to program if possible.
• Next regularly scheduled meeting will tentatively occur during the 4^th week of April, 2011.

23Feb2011

Labs / Liver Subgroup

Academia/FDA/Industry Safety Graphics Working Group

________________________________________________________________________

• Continue to review the graphics samples, focusing on the final graphics supplied by Qi and Andreas (SAS Institute graphics at below site).

• None to report

• The team reviewed all remaining graphics, completing the review of all categories, including those additional graphics supplied by Qi and Andreas (Baseline and Trending, Associated Lab Variables, LFTs and General).
• The following topics are to be discussed at the next main group meeting
  • General next steps for the subgroup (wiki, uploading graphics, programming )
  • Presentation slide templates
• The team will begin thinking about programming and next steps and will discuss at the next meeting
• The team to share the final graphic recommendations with their clinicians.

• Mac will circulate the final graphic sections (LFTs and General) for the group to share with their clinicians. The documents will be posted on CTSPedia for the main group to review as well.
• Next regularly scheduled meeting will tentatively occur during the 4^th week of March, 2011.

18Jan2011

Labs / Liver Subgroup

Academia/FDA/Industry Safety Graphics Working Group

________________________________________________________________________

• Continue to review the graphics samples, focusing on the remaining sections (LFTs and General)

• Team members can now introduce the reviewed Baseline and Trending graphics back to their respective clinicians. Comments will be shared with the team members at subsequent meetings.

• Mac and the team to research patient profile type graphics for review and inclusion in this section.
• The team reviewed all remaining graphics, completing the review of all categories (Baseline and Trending, Associated Lab Variables, LFTs and General). Additionally, a few graphics supplied by Qi were reviewed.
• The following topics are to be discussed at the next main group meeting
  • General next steps for the subgroup (wiki, uploading graphics, programming )
  • Presentation slide templates
  • Inquire about patient profile graphics in other teams
• The team will begin thinking about programming and next steps and will discuss at the next meeting

• Mac will circulate the final graphic sections (LFTs and General) for the group to share with their clinicians. The documents will be posted on CTSPedia for the main group review as well.
• Next regularly scheduled meeting will tentatively occur during the week of February 21^st, 2011.

22Nov2010

Labs / Liver Subgroup

Academia/FDA/Industry Safety Graphics Working Group

________________________________________________________________________

• Continue to review the graphics samples, focusing on the Associated Lab Variables Section

• Each team member is to try and identify a programmer who may be willing to help with the programming of the final recommended graphics. Tentatively, the programming will be split between the team. However, this activity will not begin until the graphics have been identified and reviewed with the team and their respective clinicians, and an appropriate dataset is obtained.
• At an ad hoc meeting on the 5^th of November, the remaining Baseline and Trending graphics were reviewed and the reviewed documents (with comments and annotations) have been uploaded to the CTSPedia site. An email to the main group was sent asking for their comments as well. This topic will be brought up at the next main group meeting.
• Team members can now introduce the reviewed Baseline and Trending graphics back to their respective clinicians. Comments will be shared with the team members at subsequent meetings.

• The team reviewed the Associated Lab Variables graphics and was able to complete the entire review, due to a good amount of overlap between the Baseline and Trending and this section. The updated document will be sent to the team for review. Mac to research additional patient profile type graphics for review and inclusion in this section.
• The topic of standard presentation slides, based upon the main groups template, will be brought up at the next larger group meeting.

• Graphics will continue to be reviewed within the Associated Lab Variables group, specifically patient profile samples identified. Additionally, Qi has forwarded a set of graphics that will be reviewed.
• Next regularly scheduled meeting will tentatively occur during the week of December 20^th depending on the teams availability.

20Oct2010

Labs / Liver Subgroup

Academia/FDA/Industry Safety Graphics Working Group

________________________________________________________________________

• Continue to review the graphics samples uploaded to CTSPedia, focusing on the Baseline and Trending section

• Each team member is to create a simply biography on the CTSPedia site. The link to the exact location is here http://www.ctspedia.org/do/view/GraphicsWorkingGroup/BackgroundSafetyGraphics
• Each team member is to try and identify a programmer who may be willing to help with the programming of the final recommended graphics. Tentatively, the programming will be split between the team. However, this activity will not begin until the graphics have been identified and reviewed with the team and their respective clinicians, and an appropriate dataset is obtained.

• The team continued to review the uploaded graphics in the Baseline and Trending section of the CTSPedia site. Detailed descriptions of the edits/comments for each graphic will be sent to the team in a separate email. Although some graphics are to be removed from the recommended set, these graphics will remain as back-ups.
• There was discussion around beginning to take the reviewed graphics back to the teams respective clinicians. Team members are welcome to begin this process or wait until the whole set of Baseline and Trending graphics are reviewed. An additional meeting (scheduled for 5^th November) is being arranged to finalize the review of the B&T graphics. After the review, the team will circulate to respective clinicians for review.
• As programming work will be part of the next steps for the group, Mac has asked for time at the next scheduled main group meeting to discuss the topic. There is concern about resourcing programming within each person's individual company. Note that data has been obtained by Mat Soukup and is available for use.
• Time permitting, Mac will create a very draft set of standard presentation slides, based upon the main groups template for review by the team.

• Graphics will continue to be reviewed within the Baseline and Trending group. This review should be complete at the next ad hoc meeting. Once complete, the team will update the document that has been loaded on the CTSPedia site and ask for review from the main team. In addition, the graphics will be given to clinicians for review.
• Ad hoc meeting scheduled for 5^th November from 11-12:30
• Next regularly scheduled meeting will tentatively occur during the week of November 15^th.

24Sep2010

Labs / Liver Subgroup

Academia/FDA/Industry Safety Graphics Working Group

________________________________________________________________________

• Continue to review the graphics samples uploaded to CTSPedia, focusing on the Baseline and Trending section

• Each team member is to create a simply biography on the CTSPedia site. The link to the exact location is here http://www.ctspedia.org/do/view/GraphicsWorkingGroup/BackgroundSafetyGraphics
• Each team member is to try and identify a programmer who may be willing to help with the programming of the final recommended graphics. Tentatively, the programming will be split between the team. However, this activity will not begin until the graphics have been identified and reviewed with the team and their respective clinicians, and an appropriate dataset is obtained.

• The team continued to review the uploaded graphics in the Baseline and Trending section of the CTSPedia site. The team was able to thoroughly review an additional 10 graphic samples. Detailed descriptions of the edits/comments for each graphic will be sent to the team in a separate email. Although some graphics are to be removed from the recommended set, these graphics will remain as back-ups.
• There was discussion around beginning to take the reviewed graphics back to the teams respective clinicians. Team members are welcome to begin this process or wait until the whole set of Baseline and Trending graphics are reviewed, which should be during the next scheduled meeting.
• Time permitting, Mac will create a very draft set of standard presentation slides, based upon the main groups template.

• Graphics will continue to be reviewed within the Baseline and Trending group. This review should be complete at the next meeting. Once complete, the team will upload the annotated graphs to the main CTSPedia site asking for review from the main team. In addition, the graphics will be given to clinicians for review.
• Next meeting to be scheduled for Wednesday the 20^th of October from 11-12.

17Aug2010

Labs / Liver Subgroup

Academia/FDA/Industry Safety Graphics Working Group

________________________________________________________________________

• Begin review of the graphics samples uploaded to CTSPedia, focusing on the Baseline and Trending section

• A lab dataset is still needed, however Mat mentioned that there may be one available on the CTSPedia site soon.
• Each team member is to create a simply biography on the CTSPedia site. The link to the exact location is here http://www.ctspedia.org/do/view/GraphicsWorkingGroup/BackgroundSafetyGraphics

• The team began to review the uploaded graphics in the Baseline and Trending section of the CTSPedia site. The team was able to thoroughly review 9 of the 20 graphic samples. Detailed descriptions of the edits/comments for each graphic will be sent to the team in a separate email. Although some graphics are to be removed from the recommended set, these graphics will remain as back-ups.
• Each team member is to try and identify a programmer who may be willing to help with the programming of the final recommended graphics. Tentatively, the programming will be split between the team. However, this activity will not begin until the graphics have been identified and reviewed with the team and their respective clinicians, and an appropriate dataset is obtained.
• Susan noted that there is a link to ‘Color brewer' on the General Principles site. This website is a great resource to aid in color selection.

• Graphics will continue to be uploaded to the appropriate pages on the CTSPedia site. Mac will combine graphics into a single document and circulate to the team for the next meeting, which will focus on the review of the document.
• Next meeting to be scheduled for the 2^nd or 3^rd week of September using email as there is difficulty with the Doodle pooling system for some. Agenda for the meeting will be to continue to review the individual graphics in the Baseline and Trending section and continue open discussions.

7Jul2010

Labs / Liver Subgroup

Academia/FDA/Industry Safety Graphics Working Group

________________________________________________________________________

• Review Hepatotoxicity Special Interest Group presentations
• Discuss the graphic review process and CTSPedia site

• The clinical questions document was approved by the team. It will be used as a basis for identifying graphics.

• The Hepatotoxicity Special Interest Group presentations were summarized. Susan noted that for the 2006 presentations, there were mainly standard graphics and bar charts but of interest were some principal component analysis graphics. Andreas noted that the 2007 presentations related to mostly animal models were utilized however some graphics seemed worthwhile and these were upload to the CTSPedia site. Qi reviewed 2008 and found that it was mainly clinical, explanatory and theoretical. However, one presentation by Kate Gelperin, John Senior and Ted Guo introduced the eDish tool to help decide if a patient had liver injury and contained nice graphics. Mat reviewed 2009 and noticed that most presentations were focused on post-marketing, however found one presentation from Pfizer that discussed DILI and the eDish tool. Additionally, he noted that a recurring theme was that static plots were not sufficient and an interactive, drill down tool would be much more effective. Mac reviewed 2010 and identified a few graphics from the presentations. These were upload to the CTSPedia site.
• The team discussed the topic of interactive and drill down capabilities and agreed to their importance and to raise the topic and the larger group meeting. The idea of a second development phase involving interactive and drill down capabilities was recommended.
• There still exists the need for an appropriate dataset to be utilized when developing the programming code. However, there is no immediate need and the team will continue to discuss. There was discussion about contacting PhUSE (Pharmaceuticals User Software Exchange) which is a European based group focused on the analysis and reporting of clinical data. There is an annual conference this October in Berlin. More discussion on this is needed. In addition, Qi will research the SOLVD dataset. The team to individually investigate other data set options.
• The CTSPedia site has sections for each of the categories on the clinical questions document.
• There was discussion as to the best approach for reviewing graphics. The team to submit graphics (with no specific format) to the CTSPedia site under the Labs/Liver section. Within the section are specific pages for the 4 different categories (Baseline and Trending, Associated Lab Variables, Liver Function Tests, and General). Graphics will be uploaded to the appropriate category pages.

• Graphics are to be uploaded to the appropriate pages on the CTSPedia site. The team to focus on the Baseline and Trending graphics. Mac will combined all Baseline and Trending graphics into a single document and circulate to the team for the next meeting, which will focus on the review of the document.
• The Hepatotoxicity Special Interest group site is to be added to CTSPedia with a short description.
• The team to investigate the RUCAM scale for future discussion. A link will be placed on CTSPedia.
• Each team member is to create a simply biography on the CTSPedia site. The link to the exact location is here http://www.ctspedia.org/do/view/GraphicsWorkingGroup/BackgroundSafetyGraphics
• Next meeting to be scheduled for the 2^nd or 3^rd week of August using the Doodle polling system. Agenda for the meeting will be to begin to review the individual graphics and continue open discussions.

7Jun2010

Labs / Liver Subgroup

Academia/FDA/Industry Safety Graphics Working Group

________________________________________________________________________

• We have a new member, Andreas Brueckner
• Discuss the clinical question document and path forward

• The following major milestones were proposed with accompanying timelines:
  • Final team approved compilation of recommended graphics (May10 - Oct10)
  • Final team document, including graphics, supporting code and interpretation of graphics (Nov10 - Jan11)

• John Senior, a hepatologist from the FDA joined the team meeting. He introduced the team to the Hepatotoxicity Special Interest Group, which has members from the FDA, industry and academia. The website for the group (http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/ucm071471.htm ) has numerous presentations that may offer some sample graphics. Additionally, John Senior discussed the eDish tool which not only creates the eDish plot but also offers clinicians a drill down tool enabling them to perform critical review. The team feels that the graphics group and the special interest group may be able to complement each other. The team to investigate the presentations available on the site. Ted Gao to forward a presentation concerning the eDish to the team.
• The clinical questions document was approved by the team. The final version is attached.
• The CTSPedia site is up and running and there exists a Labs/Liver section.

• The team to review the power point presentations from the special interest group. Mac to review 2010. Mat to review 2009. Qi to review 2008. Andreas to review 2007 and Susan to review 2006. Each will report back to the team at the next meeting.
• Mac to create a folder structure within the CTSPedia Labs and Liver section. Tentative folder structure is as follows, however the team to please comment on the design.
  • A Graphics subfolder will be created
  • Within the graphics subfolder will be 4 additional folders, one for each section of the questions document
  • Within each of these 4 folders will be a folder for each question. As an example, see below:
• The team to begin to collect graphics that answer the clinical questions. Once folders have been created, the team will place the individual graphics within the folders.
• Once a location is identified within the CTSPedia site to house individual biographies, each member is to upload a short personal biography.
• Next meeting to be scheduled for the most convenient time shortly after the main group meeting on the 29^th of June using the Doodle polling system. Agenda for the meeting will be to begin to review the individual graphics.

7May2010

Labs / Liver Subgroup

Academia/FDA/Industry Safety Graphics Working Group

________________________________________________________________________

• We have a new member, Ted Guo, who is very involved in the eDish and associated work at the FDA
• Discuss the clinical question document and path forward

• The following major milestones were proposed with accompanying timelines:
  • Final team approved clinical questions document (Apr10 - May10)
  • Final team approved compilation of recommended graphics (May10 - Oct10)
  • Final team document, including graphics, supporting code and interpretation of graphics (Nov10 - Jan11)

• The topic of a usable database will be addressed at the next main graphics group meeting however, the team decided to begin to investigate other possibilities. Qi mentioned the SOLVD NIH dataset and will further research the data. Additionally, team members should look into other possibilities with which they are familiar.
• There was discussion on the existing draft questions document. The revised version is attached for review. Team members should have comments back to Mac by 19May10 and Mac will circulate final draft version on 21May10.
• The team decided to wait until the next graphics group meeting to understand the progress of a graphics group website before sending proposed graphics by email. However, the team should feel free to begin to compile graphics and supporting documentation that they feel may answer the proposed clinical questions.
• Graphics that fall into the ‘Association Between Lab Variables' category may depict numerous lab parameters on a single graphic and the question was asked as to which lab parameters should be combined on any single graphic. The team to investigate this topic and discuss it with their clinicians during the questions document review. An example of grouping of lab parameters would be the ALT, AST, Bilirubin and AlkPhos scatter plot matrix graphic.

• All comments on the existing draft document should be received by 19May10.
• Revised draft document will be circulated to the team by 21May10 at which point, the team should feel free to share the document with their individual clinicians. It is recommended that the clinicians be contacted prior to this point in order to prepare them for the review. If possible, face to face meetings with the clinicians would enhance the review process. The team to have all clinician reviews of the question document complete and forwarded by 2Jun10.
• Next meeting to be scheduled for the most convenient time between 3Jun10 and 8Jun10, using the Doodle polling system.

16Apr2010

Labs / Liver Subgroup

Academia/FDA/Industry Safety Graphics Working Group

________________________________________________________________________

• Welcome new member Yaning Wang
• Discuss the clinical question document and path forward

• The team agreed upon the following high level objectives:
  • Identify clinical expertise
  • Collection and review of sample graphics, identified based upon clinical questions to be answered
  • Identify the recommended graphics
  • Acquire / create supporting code for the graphics
  • Create final document with proposed graphics, supporting code and interpretation
• The objectives will be reached through the following activities:
  • The initial step for the team is to create a clinical questions document, which will list the clinical questions that the graphics are to answer. The team will provide questions which will be compiled into a draft document. The draft document will circulate to the team and clinicians for review.
  • The team will then compile sample graphics to be incorporated into a draft document. Each graphic will be reviewed via Live Meeting with the team and any attending clinicians.
  • Supporting code will be identified / written as well as an interpretation of each graph. This data as well as the graphics will be crafted into a final document, representing the team's recommendations for lab and liver graphics to the graphics working group.
• The following major milestones were proposed with accompanying timelines:
  • Final team approved clinical questions document (Apr10 - May10)
  • Final team approved compilation of recommended graphics (May10 - Oct10)
  • Final team document, including graphics, supporting code and interpretation of graphics (Nov10 - Jan11)

• The topic of a usable database will be addressed at the next FDA Graphics group meeting.
• There was discussion on the existing draft questions document. The existing draft questions document will be revised, adding the questions that Susan identifies from the Amrit et al article. Various graphics were discussed for possible inclusion, however the team decided that a finalized question document is needed before we discuss graphics.
• Timeline to be discussed at the next FDA Graphics group meeting.

• Susan to send questions obtain from the attached article to Mac
• Mac to compile the questions into a single document which will then be sent to the team for review before the next team meeting. Comments will be incorporated and the draft document will be reviewed/approved at the next meeting. Once approved, it will be circulated to the team to be shared with their respective clinicians.
• Once the clinical questions have been compiled, the team will begin to collect graphics for review.
• Next meeting to be scheduled in approximately 3 weeks, using the Doodle polling system.

31Mar2010

Labs / Liver Subgroup

Academia/FDA/Industry Safety Graphics Working Group

________________________________________________________________________

• Clarify the goals and objectives of the subgroup.
• Identify major milestones and approximate timelines.
• Discuss next steps and path forward.

• The team agreed upon the following high level objectives:
  • Identify clinical expertise
  • Collection and review of sample graphics, identified based upon clinical questions to be answered
  • Identify the recommended graphics
  • Acquire / create supporting code for the graphics
  • Create final document with proposed graphics, supporting code and interpretation
• The objectives will be reached through the following activities:
  • The initial step for the team is to create a clinical questions document, which will list the clinical questions that the graphics are to answer. The team will provide questions which will be compiled into a draft document. The draft document will circulate to the team and clinicians for review.
  • The team will then compile sample graphics to be incorporated into a draft document. Each graphic will be reviewed via Live Meeting with the team and any attending clinicians.
  • Supporting code will be identified / written as well as an interpretation of each graph. This data as well as the graphics will be crafted into a final document, representing the team's recommendations for lab and liver graphics to the graphics working group.
• The following major milestones were proposed with accompanying timelines:
  • Final team approved clinical questions document (Apr10 - May10)
  • Final team approved compilation of recommended graphics (May10 - Oct10)
  • Final team document, including graphics, supporting code and interpretation of graphics (Nov10 - Jan11)
• Clinical expertise will be utilized primarily during two major touch points - (1) review / input on the draft questions document which will list the clinical questions that the graphics are to answer and (2) review of the proposed graphics document. Direct input from the clinicians (i.e. graphics ideas and design, clinical questions etc.) is welcomed. Additionally, clinicians are welcome to attend meetings and it is up to the respective members to forward meeting invitations to their identified clinicians.
• The question of example datasets was discussed. Mat identified that CDISC has some lab datasets that may be appropriate and publicly accessible. Each member to assess their ability to access the CDISC datasets. Also, Antonia Paredes is researching possible datasets available through Duke Clinical Research. This topic will be addressed at the next graphics working group meeting.
• The December FDA conference was discussed as Mat is to present on the graphics working group. It is the subgroups goal to have examples prepared and ready for the conference as needed.

• The team to supply questions to Mac by 16Apr10. Mac to compile the questions into a single document to be reviewed at the next team meeting. Final comments to be received by 21Apr10. Comments will be incorporated and the draft document will be circulated to the team to be shared with the clinicians. All clinical comments should be received by 7May10.
• The team to identify clinicians, and inform them of time commitment and participation.
• The team to begin compiling graphics at their leisure during development of the clinical questions document.
• Next meeting to be scheduled prior to the graphics group meeting on 21Apr10.