May 7, 2021 — You can create a new request for Data Use Agreement (DUA) review by any non-standard attachment types (like .msg files) to .pdf before.

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DUA Submission Guide November 202 1 page 2 Table of Contents Logging In 3 Creating a New Data Use Agreement Request 3 Editing a Submission . 8 Checking a Submission for Errors .. 9 Managing Related Projects . 10 Submitting a DUA for Review . 12 Checking the Status of a Submission . 14 Communicating with the Reviewer . 14 Accessing a Submission . 14 Responding to a Request for Clarifications . 18 Providing Signature on the Agreement 19 Changing Documents on a Submission . 20 Finding Signed Agreements 23 Managing Principal Investigator (PI) Proxy . 24 Changing the Agreement Creator/Primary Contact .. 25 Managing Guests with View -Only Permissions to the Study . 26 Copying an Agreement Submission 26 Amendment -Making Changes after Activation 27 Amendment -Extending the Agreement Term .. 29 Managing Agreements Initiated Prior to System Availability 29 Finding More Information 31

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DUA Submission Guide November 202 1 page 3 Logging In The Agreements system is secure, which means only authorized individuals have access to it. When you log in to the system, you get a personalized view of the information and pos sible actions pertinent to you. To log in: 1. Locate your HarvardKey and password . 2. Navigate to dua.harvard.edu . 3. Ensure the correct log in type tab is selected . 4. Enter your credentials (HarvardKey and p assword ) in the appropriate spaces . 5. Click the fiLoginfl button . 6. Once authenticated, you will be taken into the Agreements system, to your personal workspace . If you are unable to log in, contact the DUA Help Desk at duahel p@harvard.edu . Creating a New Data Use Agreement Request You can create a new request for Data Use Agreement (DUA) review by entering information into a series of online forms. The number of forms included may change based on the answers you provide. The forms tell you where to attach files to provide supporting information. The forms may contain required information identified by a red asterisk ( *), you cannot proceed without providing that information. The simplest approach is to follow the forms in order, answering the questions and clicking Continue to save your information and move to the next form. When you reach the end of the series of forms, click the Save & Exit button. To create a new DUA for review: 1. From the Agreements page (linked in the top menu), click Create Agreement . 3. Clic k Continue in the bottom right corner to move to the next page of the form. 4. Use the left navigation to go to a specific section , as appropriate.

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DUA Submission Guide November 202 1 page 4 5. To save or exit the SmartForm at any time, click on fiSavefl and fiExitfl button in the top toolbar . Exit will take you to that submission™s workspace. Yo u can continue to edit the s ubmission until you submit it for review. See Editing a S ubmission . Important! The DUA has not been submitted for review yet. For instructions, see Submitting the DUA for Review . Tips: A project team member can create a new DUA submission which is similar to a previous one, by completing the Copy Agreement activity . This will create a part ially completed form to update and further edit prior to submission for review. Where documents can be included for reference, email files (for example, .msg) cannot be attached . Please convert any non -standard attachment types (like .msg files) to .pdf b efore uploading to the system. Documents can be added to SmartForm spaces by dragging and dropping them from a location on your computer. Mouse over to identify if documents can be added from the main page. This option is not available in every attachment space. Ex. Supporting documents space in the SmartForm Listed i tems that have been added but need to be removed may be either updated or rem oved in the following ways.

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DUA Submission Guide November 202 1 page 5 An amendment submission can be handled similarly to a n initial agreement submission . For differences, see Making Changes after DUA Activation . Reference the Help Center (linked under the Agreements heading, at the top of any workspace screen) for some of the templates/forms that are requested within the SmartForm , alon g with guidance materials. A red asterisk ( *) precedes each question that requires an answer. If you cannot answer a required question at this time, or if you need to stop and continue at a later time, you can save and return to the submission later . You must provide all required information before you can submit the agreement for review. What to I nclude in a DUA SmartForm The SmartForm is the series of web -pages (or forms) where you can input specific information about a n agreement . The following section describes what information should go into eac h space of the SmartForm. Important! Completing elements of the SmartF orm or Clicking fiSave & Exit fl does not send the DUA for review . The PI , Creator , or PI Proxy must click Submit (in the submission workspace) for the submission to proceed on for the next state of review. SmartForm Section: Agreement Upload 1. *Principal Investigator/Agreement Manager . Enter the name of the Harvard Principal Investigator (PI) or lead on the agreement . This is intended to be a Harvard faculty member. The name listed here may be changed by selecting clear and typing the name in the space provided (a list will appear with names from which to select), or you can click the ellipses [–] option to search the list of names . Use the fi%fl symbol to replace porti ons of a name which are unclear or possibly not spelled correctly . This is called a fiwildcardfl character. 2. *Agreement Creator/Primary Contact . This space defaults to the name of the person who initiated the DUA request . The person listed here will automatic ally be named as a PI Proxy, will receive copies of all notifications sent to the PI . If you are removing your own name from this space, be sure that your name is listed in the PI or contacts spaces on the SmartForm, otherwise when removed, you will lose p ermission to view this submission. The name listed here may be changed by selecting clear and typing the name in the space provided (a list will appear with names from which to select), or you can click the ellipses [–] option to search the list of names . Use the fi%fl symbol to replace portions of a name which are unclear or possibly not spelled correctly . This is called a fiwildcardfl character. 3. *Upload agreement draft: (or check be box below) || If no agreement to upload, mark here for Harvard to generate fi rst draft. Either upload a draft of the document that requires signature for review by the appropriate office OR put a check in the box provided to request that Harvard generate the first draft . The form will not let you do both. Important! Iif there is a document that requires signatures, it should be uploaded here. If you are proposing an amendment that includes a document which requires signatures, upload that document to the first page of the amendment request .

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DUA Submission Guide November 202 1 page 6 4. *Harvard project t itle. The title identi fies the study throughout the system, such as in your inbox and in a reviewer’s list of submissions to review . This should be 80 characters or less and should not contain quotation marks . For amendments, it is suggested that the name of the type of amend ment be included with the title in this space (for example if the agreement title is Happiness Study Data , amendment s could be titled: Contact Changes #1 for Happiness Study Data , Term Amendment #1 for Happiness Study Data, or Period Extension #1 for Happiness Study Data. 5. *Agreement type . Select Data Use Agreement from the dropdown. Currently, Harvard is only using this system to manage DUA type agreements . When future agreement types are managed in the system, other options will appe ar for selection. 6. Description . Enter a brief description of the project, including information about any collaborations associated with this DUA . 7. Supporting Documents. Attach appropriate supporting documents in the space provided, including the following i tems (if appropriate and available): Investigator Self -Determination Form (when the DUA involves human subjects data and IRB approval will not be obtained), additional documented data information or requirements, associated contracts or agreements Note: Wh ile this is not a system -required entry, either an IRB determination letter OR a completed Investigator Self -Determination Form is required during revi ew and prior to signature, for a Data Use Agreement involving human data. Important! Make sure you attach the Investigator Self -Determination Form in the Supporting Documents section OR link your Harvard IRB application to your Agreements submission using the Manage Related Projects activity av ailable on the submission page, if your agreement covers human data. 8. *Responsible department. Indicate the name of the Principal Investigator /Agreement manager™s department for this study /agreement . Type the department name in the space provided (a list w ill appear with options from which to select), or you can click the ellipses [–] to search the list of available departments . Use the fi%fl symbol to replace portions of a word of which may be unclear or possibly not spelled correctly . This is called a fiwild cardfl character. If the department name does not appear on the list provided, contact duahelp@harvard.edu for guidance on which department to select. To fully change the department and reviewing office after a DUA is submitted : 1. Complete the Withdraw activity on the agreement in review 2. Click fiEdit Agreement fl to change the name of the department on the SmartForm 3. Click fiSavefl then fiExitfl on the SmartForm menu 4. The PI , Creator or PI Proxy must complete the Submit activity on the submission to send it back for review.

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DUA Submission Guide November 202 1 page 8 use, a nd if the data are being shared to deposit in a repository . Additional guidance regarding sharing for repository use is available on the Office for the Vice Provost for Res earch website . 2. *Are there any sponsored funding sources for this project? Mark yes or no in the space provided. If yes is marked : *Indicate the source and describe the relationship (including if funds are used to pay for the data): In the space provided, indicate the funding source ; including the GMAS fund or Project number if there is one, and cost if funds are used to pay for the data . 3. If there are any other known agreements applicable to the project /DUA, d escribe . In the space provided, describe any other associated actual or pending agreements, including Non -Disclosure Agreements (NDAs), Material Transfer Agreements (MTAs), or Licence Agreements . Any additional agreements should be attached to the supporting docum ents section on the first page of the SmartForm. SmartForm Section: DSP Additional Information 1. Which institution is providing the data ? Select the most appropriate option from those provided: Contracting Party, Harvard, Both Harvard & Contracting Party, Other . If Other is chosen : If other, please explain : In the space provided, provide information about the provider(s). 2. Describe plans for data storage: Indicate the general data storage expectations in the space provided, including if Harvard investigators will only access data stored by the provider. 3. *Will any incoming data be made available to non -Harvard personnel ? Mark yes or no in the space provide d. If yes is marked : * Describe plans to manage approval for access : In the space provided, indicate the plan for data access management. For dbGaP (or similar) requests, this should include all individuals listed as external collaborators on the dbGaP application. 4. Describe any confidentiality concerns that should be considered as part of this agreement : In the space provided, include any c oncerns about confidentiality (such as any plan to link the data with other datasets) , along with information about use for publication, if the data are identifiable/de -identified, or if data covered under policies/regulations (such as HIPAA, FERPA, GDPR, Patent, or other privacy reserving the right to remain anonymous) . Important! For all Data Use Agreements, there must be an approved Data Safety protocol. Go to https://researchsafety.harvard .edu/ and create a Safety submission . Then link the Safety protocol to your Agreements submission using the Manage Related P rojects activity available on the submission page. Editing a S ubmission You can make changes to a DUA in pre -submission and unassigned . You can also make changes if clarifications are requested . Note: steps indicated here can also be completed for an Amendment.

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DUA Submission Guide November 202 1 page 9 To edit a submission before it has been submitted : 1. From My Inbox , click the name of the submission to open it. 2. Note: If the submission does not appear in your inbox, see Accessing a S ubmission . 3. Click Edit Agreement on the left. For an Amendment , click Edit Amendment . 4. Make changes as appropriate. 5. Exit the submission . Choose one of these ways to exit: Click the Exit link. If prompted to save the submission , click Save Changes & Exit . Click Contin ue on each form, and then click the Save & Exit button s on the last page of the form . If you are unable to make edits, or edits are requested from an Ancillary Reviewer, you can still make edits to the submission without having to make a special request to the reviewer to open the record. To edit a submission after it has been submitted: 1. Go to the Agreements page ( click fi Agreements fl on the menu at the top of the page ). 2. From the All Agreements or In Progress tab , click the name of the s ubmission to open it. See Accessing a Submission for more instructions. 3. Click Withdraw on the left. Completing the Withdraw activity only affects the submission . If an amendment to an active DUA is being withdrawn, this action will only withdraw t he amendment submission and will not affect the status of the DUA . (Optional) On the withdraw activity pop u p, u se the comment box space, or document upload, to provide additional information. Do not upload any required documents here; required document s should be uploaded to the SmartForm. 4. Click OK . 5. Make changes as appropriate. 6. Exit the submission. Choose one of these ways to exit: Click the Exit link. If prompted to save the submission , click Save Changes & Exit . Click Continue on each form, and then click the Save & Exit button s on the last page of the form . 7. After edits are completed, the PI , Creator or Proxy must complete the Submit activity again, to send the submission back for continued review . Tip: Click Discard to completely remove a submission from further consideratio n. Completing the Discard activity only affects the submission . If an amendment on an active DUA is being discarded, it will only discard that submission and will not affect the current status of the agreement . Checking a Submission for Errors Checking the agreement for errors and omissions helps you include all the relev ant information, which is critical for receiving a timely review. Using these types of error checking helps you supply all the needed information: Automatic system error checking identifies any omitted answers to required questions on the form when you cl ick Continue. A red asterisk ( *) precedes each blank or question that requires an answer. Keep in mind that the system cannot catch every omission while you edit the submission if you skip questions that cause more forms to be added to your s ubmission .

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DUA Submission Guide November 202 1 page 10 Vis ually inspecting the forms to see what you may have missed . To perform a visual inspection, open the s ubmission and look through the forms in order. To open the submission , see Editing a Submission . Note especially the following items: Questions that are relevant to your request but are not required for all agreements , and Documents that should be attached . Using the Validate option to find and correct all errors before submitting the DUA . The system automatically checks for errors as pa rt of the submit activity . However , it is best to check the submission for errors before completing the submit activity , using the steps below. To use Validate option to find and correct errors: 1. Open the submission , as explained in Editing a Submission . 2. From the left navigation area, click Validate . 3. The Error/Warning Messages will appear in the left navigation , listing all the current errors and where to find them. 4. For one of the errors listed, click the link in the field go directly to the field containing the error. 5. Fill in the missing information. 6. Click Refresh in the Error/Warning Messages pane to update the list of errors. 7. Continue correcting errors until no er rors are listed. Managing Related Projects When a submission has other associated records in Data Safety, ESTR, and/or Agreements, completing the Manage Related Projects activity will connect the records across the systems so the reviewer may consider the status of associated records and any additional context of these associated records in the

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DUA Submission Guide November 202 1 page 11 review . This activity can be completed by the PI, PI Proxy, Primary Contact and members of the project team at any time in the review process. To Manage Related Projects : 1. On the main protocol/study/agreement workspace (marked in the center as fiSubmission Type: Initial Protocolfl), click the Manage Related Projects activity. 2. In the pop up, search for the related project by typing or pasting the its complete ID number into the search box (1). When it appears below, highlighted in yellow, click on the ID to choose the submission (2) . You can also click the ellipses [–] to search t he list of available submissions. One or more selected project(s) will appear on the list in the pop up . Note: You may only search for submissions to relate by their IDs. 3. Click OK to create the relationship between projects and return to the workspace . Click on the fiRelated Projectsfl tab of your protocol workspace to view related projects. Additional details about related projects will appear, including ID, name, state, date modified, and a link to the workspace of the related project. Confir m that you have selected the correct projects on this tab. Important! Notes about using Manage Related Projects : Relationships between projects are bi -directional. Once you have created a relationship between projects, it will appear (within a few moments) on the fiRelated Projectsfl tab for both submissions. You do not need to manage the relationship in both places. You may only create relationships between two initial/main studies. Follow -on submissions (such as amendments/modi fications and continuing reviews) are not available for selection . Project states may not update automatically. The correct state will always be displayed on the workspace of that project .

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