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.

It is required that your MWCCS site PI or assigned MWCCS study liaison 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:

• Appropriate Working Groups (WGs) (based on study topic areas)

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: Coordinate directly with each clinical research site about feasibility and budget.  You should receive confirmation of participation from each clinical site you plan to include in your project BEFORE you submit a concept sheet. If you need DACC support for your concept sheet, please review Guideline for Grant Research Nested in the MWCCS Needing Additional DACC Support.

Step 2: 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 3: 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 4: 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 5: 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

The Reading Center/ Data Repository Data Submission Form should be completed for any sub-study or supplement where MWCCS participant data is not coming directly to the DACC, but is instead collected elsewhere then shared with the DACC. 

Step 1: Work with all relevant study and readinv center/data repository staff to complete your Data Plan, which outlines the study and overall data submission process.

Step 2: Click Here to submite your Data Submission Form, which includes upload of your final data plans and completion of administrative  questions.

EXAMPLE of Data Submission Form

Step 3: Your Data Submission Form will be received by DACC staff. DACC staff will review the submission form for completenes and will confirm that your submission is complete or if any edits are needed for final approval via email.

How To: Request Data/Specimens

I am requesting data, specimens*, or an analytic dataset be prepared by DACC. Please note external investigators must execute a 3rd Party data use agreement (DUA) prior to requesting data from the DACC.  External investigators must also execute a 3rd party material transfer agreement (MTA) prior to requesting specimens from the 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.

EXAMPLE of the 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 Reading Center/Data Repository Data Submission Form

The Reading Center/ Data Repository Data Submission Form should be completed for any sub-study or supplement where MWCCS participant data is not coming directly to the DACC, but is instead collected elsewhere then shared with the DACC.

Step 1: Work with all relevant study and reading center/data repository staff to complete your Data Plan, which outlines the study and overall data submission process.

Step 2: Click here to submit your Data Submission Form, which includes upload of your final data plan and completion of administrative questions.

EXAMPLE of the Data Submission Form

Step 3: Your Data Submission Form will be received by the DACC staff. DACC staff will review the submission form for completeness and will confirm that your submission is complete or if any edits are needed for final approval via email.