2018 Course Stages and Task List
Points are used to determine the minimum threshold required to be granted a completion certificate for the course. Timely completion of each task below earns 3 points (unless otherwise specified). A penalty of 1 point is applied for each task that is completed within 1 week of the due date. A penalty of 2 points is applied for each task that is completed great than 1 week after the due date. No points are given for uncompleted tasks. No points are given for completing the anonymous residential course evaluations, but you are strongly encouraged to evaluate each session. Links to survey instruments in Qualtrics will be provided. All this information and more are in the course syllabus.
Tasks and due dates are tracked by logging your work using the google form - http://bit.ly/ctmcCheck
- Demographics survey (note we collect this during the application process, but also collect it here after selecting the cohort. This is requested by the NIH) - https://umichumhs.qualtrics.com/jfe/form/SV_9WXKaoshnPPHXrn
- Review 2018 Syllabus and Expectations document
- Attend or review the introduction webinar
- Review instructions for Blue Jeans and practice logging in (test http://bluejeans.com/111)
- Complete travel form - https://umich.qualtrics.com/jfe/form/SV_7aOGfQFTfOEp3N3
- Read and review the NINDS Transparency in Reporting Guideline: (no points) https://www.ninds.nih.gov/sites/default/files/transparency_in_reporting_guidance_1.pdf
Spring/Summer Webinar Series:
All webinars are generally held at 12PM EST (https://bluejeans.com/7342322138) – please use a computer with webcam, or the Blue Jeans app if possible. If you must use a phone call in numbers can be found on the Blue Jeans website. DO NOT CALL AND USE COMPUTER AUDIO.
Some webinars are designated as “office hours.” During these, it is expected that you will review the assigned pre-recorded webinar on YouTube. Then during the “office hours” time block we will have some of the course faculty available to answer questions (both from the relevant webinar, but if other clinical trials questions come up we will answer those too.)
Real-time attendance at and participation in the webinar series is strongly recommended. Recordings will be posted to the course website https://nett.umich.edu/training/ctmc/ctmc-webinars for those who cannot attend in real time. 3 points are earned if completed within 1 week of the webinar; 2 points if within 2 weeks; 1 point if done before the August in-person course.
Please EVALUATE each webinar: https://umichumhs.qualtrics.com/jfe/form/SV_3rSmFKitJ1DTlRP
See the CTMC Webinars page for a list of webinars for 2018 and previously.
AMA Credit Designation Statement
The American Academy of Neurology Institute designates this enduring material for a maximum of 8 AMA PRA Category 1 Credit(s)™. Each webinar is eligible for up to 1 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
This activity has been planned and implemented in accordance with the accreditation requirements of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the American Academy of Neurology Institute, the University of Iowa, Los Angeles BioMed, and the University of Michigan. The American Academy of Neurology Institute is accredited by the ACCME to provide continuing medical education for physicians.
In order to obtain CME credits, you must complete an evaluation form (a link to the evaluation form will be provided during webinar) and provide your email address.
Spring Small Group Sessions:
The goal of the small group sessions is protocol and proposal development. Small groups will be 60- minute sessions, which will occur by Blue Jeans video teleconference. There are two or three core faculty members in each small group. Each group has a biostatistical and clinical core faculty member. Each trainee will be primarily assigned to one of the group core faculty members who will be responsible for primary feedback on submissions. Each of the core faculty within a group will be familiar with all of the projects in the group.
Session 1 Introduction and Specific Aims Part 1:
- Complete your project information form (potentially you already did this as part of your application) https://umich.box.com/s/w0vvu871oqyd60t6pkrndkr0capbrzph
- As soon as possible and no later than 48 hours prior to the first session, upload a draft specific aims page AND the project information form into your Box folder for the faculty to review.
- Prepare a five-minute introduction presentation about your clinical trial and why it is important. Each trainee will present (with 5 minutes of feedback from faculty) during the first session. Do not use slides. You should talk into your webcam. You should use the project information form as a guideline for the high yield topics you should cover during the presentation (e.g. disease, phenotype, preclinical justification).
Session 2 Specific Aims Part 2:
- Review Chapter 7 “Selecting Outcome Measures” in Ravina (course text). https://umich.box.com/s/clhd0b3viwenrah7e6zu8084yk9k341v Someone reading your specific aims page should be able to understand your main outcome measure.
- Turn in revised specific aims page in 48 hours prior to session 2 by uploading the assignment in Box.
- Core faculty will provide feedback on submitted outcome measure document during session 2 (10 minutes each)
Session 3 Background and Significance:
- Review Chapters 2 and 4 in Ravina (course text)
- Prepare a 1-3-page significance section for a grant (involving your clinical trial idea). This should include references. The goal is to let the reader understand why your disease is significant and your proposed treatment would represent a significant step forward.
- Upload document to Box at least 48 hours prior to session 3
- Core faculty will provide feedback on hypotheses and objectives document during session 3 (10 minutes each)
- Biostatistics trainees (if applicable) should upload a list of questions about each study concept to the Box folder of each clinical trial.
Session 4 Protocol 1:
- Review Chapter 27 in Ravina (course text).
- Start building the relevant parts of your trial protocol. Download the NIH trial template here https://umich.box.com/s/148e10106ep0i5xafrail32h6m0ko9lf
- For the first protocol session please complete sections 1 (overview), 2, (introduction – which should be derived from significance section) and 3(objectives and endpoints) please upload to Box so core faculty can review 48 hours prior to session.
Session 5 Protocol 2:
- Revise sections 1-3 of protocol based on feedback from first session
- Draft protocol sections 4 5 and 6
- Biostatistics trainees (if applicable for small group) should review JAMA article on Statistical Analysis Plans (and template)
- Biostatistics trainees should upload a draft SAP for each project.
- Core faculty will provide feedback on submitted protocol shell during session 5 (10 minutes each)
Session 6 Procol 3:
- Revise sections 1-6 of protocol based on feedback from second session
- Draft protocol sections 8 (assessments) and 9 (statistical analysis plan)
- Biostatistics trainees should upload a revised SAP for each project.
Core faculty will provide feedback on submitted protocol shell during this session.
Session 7 Budget:
(Note some small groups may not be able to schedule a 7th session or may need to use 7th session on additional protocol development.) Please complete a draft budget prior to the residential course.
- Review the following article http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2793732/
- Review the following website and look at the schema examples https://research.unc.edu/files/2016/08/KOURY-AND-MCCOLL-3500-Budget-Development-2016-OSR-Symposium.pdf
- Prepare budget and personnel justification draft. (Consider getting an example from your mentor and/or your departmental research administrator)
- Turn draft budget in to core faculty members at least 48 hours prior to session 7 by uploading the assignment in Box.
Full Protocol Draft:
We recognize that not all elements of the design, sample size and statistical analysis plan will be worked out after the small group sessions. It is important to attempt to fill out as much of a complete protocol template as possible, so that it will be feasible for you to revise and finalize this document while you are at the residential course. Note: some elements of the protocol template may not apply (or may not seem to apply) for early phase trials so please mark sections as not applicable. These sections will be deleted when you finalize the protocol.
- Prepare first complete draft of your clinical trial protocol
- Turn draft protocol in to core faculty members by uploading to Box.
A variety of course lectures and other activities will occur during the summer residential course. A complete agenda will be provided closer to the residential course. Attendance at the large group lectures is required. Readings will be assigned by lecturers from the residential course. A reading list will be provided in Box.
Fall Webinar Series:
Fall Small Group Sessions:
The goal of the fall small group sessions is continued protocol and proposal development. Small groups will be 90-minute sessions, which will occur by Blue Jeans video teleconference. The goal is to work towards getting a full version of a proposal (specific aims page plus 6 to 12-page grant depending on funding mechanism).
Session 8 Research Strategy/Research Plan - Major first draft of research proposal
- Prepare a draft of the research strategy/research plan appropriate to the proposed grant mechanism. (The specific aims, and background/significance should be done already. At this point you will need to add sections for Innovation and Approach).
- Turn research strategy/research plan in to core faculty members at least 48 hours prior to session 8 by uploading the assignment in Box.
The research plan describes the proposed research, stating its significance and how it will be conducted. Remember, your application has two audiences: the majority of reviewers who will probably not be familiar with your techniques or field and a smaller number who will be familiar.
- https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/write-your- application.htm
- http://www.niaid.nih.gov/researchfunding/grant/strategy/pages/3default.aspx (Particularly “Write the Research Strategy”). Provides a nice overview of how to write scientifically, and how to write a grant using the current strategy. The caveats are it is by NIAID, and it is targeted somewhat towards basic science. (However, science is science, and testable hypotheses are an important part of that. Particularly thinking about how to communicate clearly is something that this covers well
- http://www.niaid.nih.gov/researchfunding/grant/Pages/appsamples.aspx has sample grant applications. They are almost all pre-clinical/translational. The McCune R03 application actually uses humans, and is most helpful. I recognize it is a completely different disease, design, etc. I think the above link “writing the research strategy” will be more helpful. We will work to provide a contemporary, single site clinical trial example.
- While not in the latest format, the following grant proposal shows how a research strategy for a clinical trial might be presented. Generally, you will want to organize the sections based on the modern requirements for Significance, Innovation, and Approach. The general strategy used to define the approach in this proposal should translate to the current grant writing instructions for NIH. In addition, there is a push for linking to the biological basis and scientific premise for your experiment and this will also need to be weaved in. https://umich.box.com/s/6201xeey6xlp3j87rentyphw89ex5vfk
Session 9 Human Subjects Protection Sections:
- Draft the human subjects’ protection sections of your proposal, appropriate to the proposed grant mechanism. (Due to core faculty 48 hours prior to HSP session).
- Turn Human Subject Protection document in to core faculty members at least 48 hours prior to session 9 by uploading the assignment to Box
Session 10 Wrap Up and Finalize Proposal:
- Wrap up and discuss any loose ends and plans for submission of grant/implementation of trial.
- A complete draft of your proposal revised based on feedback from above small groups and other iterative feedback is due by October 15. However, small groups completing proposals substantially earlier than this may be able to have study sections accelerated. You should include all required elements of your grant proposal (biosketches, budget, human subjects protection, research plan, specific aims, facilities and resources). If you are using an alternative mechanism to NIH (i.e. foundation or AHA) you may include a cover letter that describes the mechanism and the required elements. You may include your protocol as an appendix. You should not submit your protocol as a research plan as the structure of a grant proposal research plan is different from a protocol.
- Turn in all documents for review in the Mock Study Section by uploading the assignment in the submission portal. A link to the submission portal will be provided in future. Proposals without required elements will not be included in the Mock Study Section.
- Complete Evaluations of Small Groups
Mock Study Section:
Trainees will be expected to turn in a protocol and proposal for inclusion in the Mock Study Section.
DATES TO BE ANNOUNCED FOR FIRST WEEK OF NOVEMBER.
A consent form must be included as an appendix, as well as a screening and recruitment plan. A safety monitoring and adverse event reporting plan must also be included as an appendix if not addressed in protocol. The session will be recorded for later review by the trainees. Trainees will be permitted to attend sessions and observe but will generally only speak if called upon. Written feedback from the reviewers will be provided following the mock study section.
Reunion at American Academy of Neurology Annual Meeting (Spring 2019):
Trainees from the current and previous cohorts are invited to join the annual AAN-NINDS/CTMC Meeting and Reception at the AAN Annual Meeting. If you are unable to attend the reception, you will be asked to prepare an abbreviated single slide update to be shared at the reception. If you are able to attend the reception in person, you will be asked to prepare a 2-slide update of your project to present.
We regret that we cannot provide travel to the AAN meeting. Please email NINDS-CTMC-Info@umich.edu if you have any questions.