Investigator How-To’s

How To:

  1. Submit a Concept Sheet
  2. Submit a Revised Concept Sheet
  3. Submit a Concept Sheet Addendum
  4. Request Data/Specimens
  5. Submit a Manuscript or Abstract
  6. Submit a Publication

All concept sheets (CS), manuscripts, abstracts, and publications are now maintained in our data management system, DACCTrack. Investigators can access their projects through a unique DACCTrack link (called an Investigator View) provided by the Data Analysis and Coordination Center (DACC).

How To: Submit a Concept Sheet

All investigators (who are not a grant-supported investigator at a MWCCS clinical research site) should have a study liaison. A study liaison is responsible for:

  • ensuring the investigator is aware of any data/specimen limitations
  • making sure that persons with appropriate scientific expertise have provided input
  • confirming the investigator is adherent to the MWCCS Concept Sheet and Publication Policy

Please contact the DACC (mwccs@jhu.edu) if you need a study liaison assigned to your project.

Your MWCCS site PI or assigned MWCCS study liaison should review and approve your CS prior to submission for CS review. The typical review period for CS review is 10 business days.

Option 1: I am planning a multi-site investigation that does not require additional data collection (i.e., I seek to analyze existing data).

Step 1: Submit a MACS/WIHS Combined Cohort Study Concept Sheet Submission Form

  • This online form collects administrative information about your proposed project.
  • You will also be prompted to upload a Research Plan outlining your proposed science.

Step 2: DACC staff will review the CS for completeness, assign a README# (tracking number), and assign the appropriate reviewers. In this case:

Step 3: Concept Sheet Approval/Revision Requested

  • If the assigned WG(s) approve your CS, you will receive an official approval letter via email with a link to your unique Investigator View in DACCTrack.
  • If the assigned WG(s) request a revision, you will receive a revision request letter via email with a link to your unique Investigator View in DACCTrack (includes a link to submit a Revised CS).

Step 4: Co-author Assignment

  • DACC staff will solicit co-authors for your approved CS. You will receive an email from DACC when your co-author list is complete.
  • You may access your co-author list in your unique Investigator View in DACCTrack.
  • Assigned co-authors should be listed on all abstracts and manuscripts that are submitted as part of the aims outlined in the approved CS.

Option 2: I am planning a multi-site investigation that proposes new data collection, new specimen collection, or specimens to be requested from the central repository.

Step 1: Submit a MACS/WIHS Combined Cohort Study Concept Sheet Submission Form

  • This online form collects administrative information about your proposed project.
  • You will also be prompted to upload a Research Plan outlining your proposed science.

Step 2: DACC staff will review the CS for completeness, assign a README# (tracking number), and assign the appropriate reviewers. In this case:

  • Appropriate Working Groups (WGs) (based on study topic areas)
  • Project Director Reviewer (PDR) if proposing new data collection or new specimen collection.
  • Lab Reviewer (LR) if requesting new specimen collection or requesting to withdraw specimens from the central repository.

Step 3: Concept Sheet Approval/Revision Requested

  • If the WG(s), PDR, and LR approve your CS you will receive an official approval letter via email with a link to your unique Investigator View in DACCTrack.
    • If you are proposing new data collection or new specimen collection, the CS will receive Provisional Approval. Your CS will require full EC discussion and approval during the annual MWCCS protocol review/visit changes process.
  • If the WG(s), PDR, or LR request a revision, you will receive a revision request letter via email with a link to your unique Investigator View in DACCTrack (includes a link to submit a Revised CS).

Step 4: Co-author Assignment

  • DACC staff will solicit co-authors for your approved CS. You will receive an email from DACC when your co-author list is complete.
  • You may access your co-author list in your unique Investigator View in DACCTrack.
  • Assigned co-authors should be listed on all abstracts and manuscripts that are submitted as part of the aims outlined in the approved CS.

Option 3: I am planning a single site investigation that proposes to utilize and/or collect data/specimens from one MWCCS site only, and/or plans to withdraw specimens from any MWCCS central repository.

Step 1: Submit a MACS/WIHS Combined Cohort Study Concept Sheet Submission Form

  • This online form collects administrative information about your proposed project.
  • You will also be prompted to upload a Research Plan outlining your proposed science.

Step 2: DACC staff will review the CS for completeness, assign a README# (tracking number), and assign the appropriate reviewers. In this case:

  • PI from the specific MWCCS site indicated in your CS submission.
  • Project Director (PD) from the specific MWCCS site indicated in your CS submission (if additional data or specimens will be collected).
  • Lab Reviewer (LR) if you propose the withdrawal of specimens from any of the MWCCS central repositories.

Step 3: Concept Sheet Approval/Revision Requested

  • If the PI (and PD when applicable) approves your CS, you will receive an official approval letter via email with a link to your unique Investigator View in DACCTrack.
  • If the PI (or PD when applicable) requests a revision, you will receive a revision request letter via email with a link to your unique Investigator View in DACCTrack (includes a link to submit a Revised CS).

How To: Submit a Revised Concept Sheet

Reviewers may request a CS revision if there are issues with the availability of data/specimens/types of participants that would prevent the research from taking place, important design issues or flaws, and/or overlap with approved research. Revisions to a CS are made prior to approval.

Step 1: Go to your unique Investigator View in DACCTrack. If you do not have the link to your unique Investigator View, please click here to submit a request to look up your  Investigator View link.

Step 2: Once you are in your Investigator View, you will see a Review Status called *Revision Requested on the left-hand side. Listed below this status are any README#s that require revision. Find the README# that requires a revision, and then scroll to the right to find the Revision/Addendum Submission Link.

Step 3: Click on the Revision/Addendum Submission Link. You are now looking at a pre-populated form for this specific CS. Proceed to complete the form and upload the Research Plan with the revised information highlighted in yellow or indicated by track changes in Microsoft Word.

Step 4: Complete the form and click submit.

Step 5: Your revised CS will be assigned to the original reviewers who requested the revision. The reviewers have seven business days to review the revised CS and render a decision to approve or request another revision if their questions were not adequately addressed.

How To: Submit an Addendum to an Already Approved Concept Sheet

Investigators may submit an addendum to a previously approved CS if they are requesting additional resources (e.g., data or specimens). The CS will retain the same README number assigned to the initial project.

Some addendums will need to be submitted as a new, initial CS and will receive a new README#. If any of the following conditions are met, the addendum will need to be submitted as a new, initial CS:

  • proposes the addition of aims
  • proposes the addition of substantially different data elements (for collection and/or analysis) that will result in publication of an additional manuscript
  • will significantly expand the scope of the CS

Step 1: Go to your unique Investigator View in DACCTrack. If you do not have the link to your unique Investigator View, please click here to submit a request to look up your Investigator View link.

Step 2: Once you are in your Investigator View, you will see a Review Status called *Approved on the left-hand side. Listed below this status are all of your approved projects. Find the README# that you would like to amend, and then scroll to the right to find the Revision/Addendum Submission Link.

Step 3: Click on the Revision/Addendum Submission Link. You are now looking at a pre-populated form for this specific CS. Proceed to complete the form and upload the Research Plan with the edited information highlighted in yellow or by using track changes in Microsoft Word.

Step 4: Complete the form and hit submit.

Step 5: Your CS addendum will be assigned to the appropriate reviewers. The reviewers have 10 business days to review the CS addendum and render a decision to approve or request a revision.

How To: Request Data/Specimens

I am requesting data, specimens*, or an analytic dataset be prepared by DACC.

Step 1: Go to your unique Investigator View in DACCTrack. If you do not have the link to your unique Investigator View, please click here to submit a request to look up your  Investigator View link.

Step 2: Once you are in your Investigator View, you will see a Review Status called *Approved on the left-hand side. Listed below this status are all of your approved projects. Find the README# that you want to request data/specimens/analytic dataset for, and then scroll to the right to the DACC Resource Request Form link.

Step 3: Click on the DACC Resource Request Form.

Step 4: Complete the form and hit submit. DACC will place your request in a queue in order of date received. An appropriate programmer will be assigned once your project is ready to move forward.

*Not all specimen types may be available at every visit.

How To: Submit a Manuscript or Abstract for EC review

Step 1: Work with your co-authors to write the manuscript or abstract. We encourage inclusion of assigned co-authors early in the process (before the final draft of the manuscript is ready).

Step 2: Approval from all assigned co-authors is required prior to manuscript or abstract submission to the MWCCS EC for review and approval.

Step 3: Fill out the MACS/WIHS CCS Manuscript, Abstract & Publication Submission Form

Step 4: You will be asked to upload your manuscript or abstract to this form.

Step 5: Your manuscript or abstract will be received by DACC staff. DACC staff will review the submission form for completeness and will confirm that the assigned MWCCS co-authors have been included. You will receive an automated email when the manuscript or abstract has been circulated to the EC for review and approval.

Step 6: The MWCCS EC has seven business days to review a manuscript and three business days to review an abstract.

Step 7: DACC will collate and communicate all EC feedback to the investigator. If you do not receive feedback within the prescribed review period, you may submit your manuscript to a journal or abstract to a conference.

How To: Submit a Publication

Investigators are required to submit all published manuscripts to the NIHMS system for assignment of a PMCID number. Failure to submit may result in future restrictions on the use of MWCCS data/specimens. Some journals will submit to the NIHMS system on your behalf (see list here).

After completion of the analyses defined in the MWCCS CS (i.e., dissemination of study findings in the form of a manuscript submitted to a peer-reviewed scientific journal):

  • Investigator must destroy all copies of the limited dataset within 60 days.
  • Investigator must send copy of all primary data to DACC (MWCCS@jhu.edu)
  • If specimen testing, all laboratory results must be sent to MWCCS for archival purposes (MWCCS@jhu.edu)

Once your manuscript has been published and the PMCID number has been assigned, fill out the MACS/WIHS CCS Manuscript, Abstract & Publication Submission Form. This allows DACC to track MWCCS publications and add all new publications to the MWCCS Publications List.