ELECTRONIC SITE DELEGATION LOG (esdl) USER MANUAL

Version 1.0 24May16 ELECTRONIC SITE DELEGATION LOG (esdl) USER MANUAL

- Table of Contents - 1. INTRODUCTION... 3 Background... 3 Purpose of the Site Delegation Log... 3 TNCC Contacts... 3 2. SYSTEM REQUIREMENTS... 4 3. OVERVIEW AND BASIC FUNCTIONALITY... 4 Login/Navigate to the Electronic Site Delegation Log... 4 Components of Electronic Site Delegation Log... 6 Available Trainings... 6 Online Training... 6 Training Slides... 8 Demo Website... 8 Frequently Asked Questions (FAQs)... 9 4. esdl MAINTENANCE PAGE... 9 Overview... 9 Portlets...10 Members at Site...10 Associated Protocols...11 Associated Tasks...11 Site Certification...12 Adding New Members to the esdl...12 Adding a Member from another site...14 Removing a Member Added in Error...16 Prior to Protocol Title/Task Assignment...16 Post Protocol Title/Task Assignment...17 Assigning a Protocol and Study Title to Member...17 Removing a Protocol Title Added in Error...23 Prior to Certification...23 Post Certification...24 Adding New Tasks to a Member...24 Removing a Task Added in Error...31 Prior to Certification...31 Post Certification...32 Adding End Dates to Protocol Titles...32 Adding End Dates to Tasks...34 Submit for Certification...36 Submit for Certification...38 5. CURRENT esdl VIEW PAGE...41 Overview...41 Functionality...41 6. USER MAINTENANCE PAGE...43 Overview...43 Adding a New User to esdl Only...44 Adding a New User to esdl and TrialNet Member s Website...45 Correcting a User...48 Deactivating a User...51 7. esdl REPORT...53 Page 2 of 54

1. INTRODUCTION The Electronic Site Delegation Log (esdl) is the component of the TrialNet online data capture system used to record and manage all study staff members significant study-related duties for TrialNet studies. This user manual provides an overview of esdl features as well as step-bystep instructions on how to navigate the system. Background The TNCC utilizes the Site Delegation Log provided by each site to: Ensure the member directory is current and that study specific correspondence is being sent to all appropriate stakeholders. Ensure each person s permissions in the online system are appropriate. Track site study staff s training by required section or module based on delegated responsibilities. Adherence to 21CFR11.10. Purpose of the Site Delegation Log This log should provide a comprehensive list of study staff members and the duties that have been delegated to them by the Principal Investigator. It is required for both observational and interventional clinical research studies. To fulfill the requirements stated in ICH GCP E6 Guideline Section 4.1.5: the investigator should maintain a list of appropriately qualified and trained persons to whom the investigator has delegated significant trial related duties. To meet the expectation of the FDA guidance Investigator responsibilities - Protecting the Rights, Safety and Welfare of Study Subjects, in particular Section 3 which clarifies the investigators responsibility to supervise the conduct of the clinical investigation and to protect the rights, safety and welfare of participants in drug and medical device clinical trials. To address the requirement in Section 8 of ICH GCP 8.3.24 signature sheet to document signatures and initials of all persons authorized to make entries and/ or corrections on CRFs. Documents study- specific roles and responsibilities assigned to all staff on the study team by the Principal Investigator (PI). FDA regulations 21 CFR 312.53 state a commitment by the investigator that he or she will ensure that all associates, colleagues, and employees assisting in the conduct of the study (ies) are informed about their obligations. TNCC Contacts For further assistance with the esdl, please contact the TNCC at Regulatory@epi.usf.edu. Page 3 of 54

2. SYSTEM REQUIREMENTS In order to use the Member s Website and the esdl sites will need to have: Hardware and software: Access to a PC running Windows 7, 8.1, or 10. Internet Explorer 11.0 or higher. Internet connectivity. High-speed broadband or better connection is recommended. Adobe Reader is required to download some of the documents for this study. To download the Adobe Reader go to www.adobe.com and click on the Get Adobe Reader button. 3. OVERVIEW AND BASIC FUNCTIONALITY Login/Navigate to the Electronic Site Delegation Log Step 1. Procedure to login and navigate to the esdl: Log into TrialNet Members Site: http://www.diabetestrialnet.org/members.htm: Step 2. Under Members Login Screen enter User Name and Password: Page 4 of 54

Step 3. Navigate to the My Site portlet: Step 4. Under the My Site portlet, select Electronic Site Delegation Log : Page 5 of 54

Step 5. A new window will appear: Components of Electronic Site Delegation Log The esdl application is composed of the esdl maintenance page, the current esdl view page, and the user maintenance page. Each component of the esdl will be reviewed in more detail in the succeeding sections of this manual. Available Trainings The TNCC has developed additional training for all members to utilize in addition to the user manual. At least one member at each site should be trained on the esdl. Online Training The training video is available online. A site must have Windows Media Player in order to access the videos; they can be viewed at any time by navigating to the online TrialNet media center as follows: Page 6 of 54

Step 1. From the main TrialNet members website, on the left side navigation bar, click on the TNCC Training Videos link: Step 2. A new window will open to the media center. Click on the Training link: Step 3. Select the TrialNet Training General Members Website Link: Page 7 of 54

Step 4. A list of available videos will display. Select the TrialNet Training Electronic Site Delegation Log (esdl) link: Step 5. Information about the video will display. Select the button View Presentation for Free. Step 6. The video will open in Windows Media Player. Training Slides The training slides (without audio) are posted on the My Site portlet located on the main page of the TrialNet Member s Website under the esdl User Manual link: Demo Website For additional practice, members can access the TrialNet demo website and test out the esdl functions. No changes will officially save in the demo website. All official changes must be completed on the esdl located in the TrialNet Members Website: Page 8 of 54

Frequently Asked Questions (FAQs) The esdl FAQs are posted on the My Site portlet located on the main page of the TrialNet Member s Website under the esdl User Manual link: 4. esdl MAINTENANCE PAGE Overview The esdl Maintenance Page is an editable page which allows a site to make edits to the sitespecific site delegation log. The function of this page where sites will be able to: Review all members currently listed on site-specific esdl Assign protocol titles and tasks to each member Add start and end dates to each member Submit draft changes to the PI for site certification Page 9 of 54

Portlets Members at Site From the Members at Site portlet, a member can view all members at their respective site. Once a member is added to the electronic site delegation log via the User Maintenance page, the member will show in this portlet: 1. Lists the site the current member accessing the esdl is located 2. Add a member to esdl from another site (if applicable) 3. Select a member to edit protocol and related tasks 4. Remove a member entered in error prior to adding titles/tasks Page 10 of 54

Associated Protocols Once a member is selected from the Members at Site portlet, the delegated protocols will appear on the right side: 1. Lists protocols the member is associated with at site 2. Lists study title for respective protocol 3. Lists certification status, date certified, start date, and end date (if applicable) 4. Add protocol, title, and start date 5. Select protocol to edit related tasks per protocol 6. Select to add end date to member per protocol Associated Tasks Once a protocol is selected from the Associated Tasks portlet, the delegated tasks will appear on below on the Associated Tasks portlet: 1. Lists tasks the member is assigned 2. Lists start date, and end date (if applicable) 3. Add tasks and start/stop end date 4. Select associated tasks to edit Page 11 of 54

Site Certification From the Site Certification portlet, a member will submit requested changes on the esdl to the site PI for certification: 1. Lists state of current esdl (Draft or Certified) 2. Lists last date of certification 3. Lists member who last certified the esdl 4. Field for entering text prior to submitting for certification 5. Submits draft esdl to site PI for certification Adding New Members to the esdl To add a new member to the site esdl: Navigate to User Maintenance Page: Page 12 of 54

Step 2. Refer to Section 6 for guidance on how to add a member to the esdl. Step 3. Once a member is added to the esdl, navigate back to the esdl Maintenance page. The name will now appear under Members at Site : Page 13 of 54

Adding a Member from another site If a new member is currently active on another site s delegation log and will perform study tasks at another site, the member does not need another log in credentials. To add a new member from another site: From the Members at Site portlet, select the addition sign on the top right hand side: Step 2. The Member Maintenance window will appear. From this window, enter the first AND last name of the member that should be added and then select search : Step 3. If a name was entered in error, select clear, which will clear the field(s). Page 14 of 54

Step 4. After the search has completed, a name (or names) will appear, along with the email address associated with the name(s): Step 5. Select the check box on the left hand side of the member that should be added: Step 6. Select Add/Update to add the member to the esdl. Select Cancel to cancel addition: Page 15 of 54

Step 7. The member will now appear on the Members at Site portlet. Please note: The site PI must still approve this request before changes can take effect. If a member listed at another site is added and the request is approved by the site PI, the member will have access to current site data while using their original log in information. The member from another site will not need multiple log in credentials to access to the TrialNet Member s Website. Removing a Member Added in Error Prior to Protocol Title/Task Assignment A member may be removed from the Members at Site portlet only if there have been no protocol titles added to the draft esdl. If a member was erroneously added to the esdl: From the Members at Site portlet, select the delete sign on the right hand side of the member that should be removed: Page 16 of 54

Step 2. A window will appear, confirming the request: Once the request has been confirmed, the member will no longer show under the Members at Site portlet. Post Protocol Title/Task Assignment If a member had a protocol title/task added to the esdl, the member cannot be removed from the system. In order to document the error, an end date should be added the protocol title and the end date should be the same date as the start date. The error should be documented in the comment field prior to submitting for certification, explaining the circumstances. Assigning a Protocol and Study Title to Member Each member listed on the esdl should have a study title listed for each protocol they are assigned. To assign a new protocol and study title to a member: From the Members at Site portlet, select a member by clicking on the check mark box on the left hand side: Page 17 of 54

Step 2. Navigate to the Associated Protocols portlet. Under this portlet, select the addition sign: a. Once a member is selected, the protocol, title, and start date for the member can be entered in the Protocol Maintenance window b. If the addition sign is selected without selecting a member, an error message will appear: Step 3. The Protocol Maintenance window will now appear. From this window, the protocol, title, and start date can be entered: Page 18 of 54

a. To select the protocol, select the drop down arrow on the right hand side and select the appropriate protocol: b. To select the study title, select the drop down arrow on the right hand side and select the appropriate title: Page 19 of 54

i. For sites with site-specific roles not found under Study Title, select Add Site Specific Title and manually enter role: Once a Site Specific Title has been entered and added, it will appear in the dropdown menu: ii. A list of all study titles and their definitions is provided in Table 1. Table 1. Overview of Study Title Definitions Study Title Diabetes Educator* Laboratory Technician Pharmacy Technician Phlebotomist Definition A health professional who possesses comprehensive knowledge of and experience in prediabetes, diabetes prevention, and management and is certified in diabetes education. There are no system roles assigned with this title. A person trained to perform most lab tests in research. There are no system roles assigned with this title. A person who prepares and dispenses prescriptions under the supervision of a pharmacist. There are no system roles assigned with this title. A health professional who is trained in the process of making a puncture in a vein for purposes of removing or collecting blood. There are no system roles assigned with this title. Page 20 of 54

Primary Study Coordinator Principal Investigator Recruitment Coordinator Regulatory Coordinator Research Assistant Study Coordinator Study Drug Pharmacist Sub-Investigator Site Specific Title A person responsible for conducting clinical research using good clinical practice (GCP) under the auspices of the Principal Investigator. The Primary Study Coordinator title should be assigned to any individual in charge of a particular protocol. With this title, the system will assign roles in the system to receive IRB approval lapse notifications, and to be listed as site contact person on the TrialNet Member s Website and site coordinator. All Clinical Center members with this role will be included on all affiliate site emails. A healthcare professional in charge of a research grant at a site. With this title, the system will assign roles in the system to receive IRB approval lapse notifications and to be listed as the main site PI. A person responsible for recruiting participants into research studies under the auspices of the Principal Investigator. A recruitment coordinator at a Clinical Center may also be responsible for recruiting additional affiliates to be a part of the TrialNet network. There are no system roles assigned with this task. A person responsible for ensuring that the site complies with its outside regulatory requirements and internal policies. There are no system roles assigned with this title. A person responsible for assisting in the conduct of clinical research. There are no system roles assigned with this title. A person responsible for conducting clinical research using good clinical practice (GCP) under the auspices of the Principal Investigator. With this title, the system will assign the role of site coordinator. A healthcare professional licensed to prepare, compound, and dispense drugs upon written order (prescription) from a licensed practitioner. There are no system roles assigned with this title. A person designated and supervised by the investigator at a trial site to perform critical trial-related procedures and//or to make important trial-related decisions. There are no system roles assigned with this title. A site-specific title should only be manually entered if no other title listed on the dropdown menu is acceptable. There are no system roles assigned with this title. Page 21 of 54

c. To select the study title, select the calendar icon on the right hand sand and select the appropriate start date: Please note: A start date cannot be more than one day in the future. If a future date is selected, and error message will appear: Page 22 of 54

Step 4. Select Add/Update to add new protocol/title to the member. Select Cancel to cancel addition: Once a protocol, title and start date have been added for a member, the assigned protocols and titles will now appear in the Associated Protocols portlet when the member is selected from the Members at Site portlet: Removing a Protocol Title Added in Error Prior to Certification A protocol title may be removed from the Associated Protocols portlet only if the esdl change has not yet been certified. If a protocol title was erroneously added to a member on the esdl: From the Associated Protocols portlet, select the delete sign on the right hand side of the protocol title that should be removed: Page 23 of 54

Step 2. A window will appear, confirming the request: Once the request has been confirmed, the protocol title will no longer show under the Associated Protocols portlet. Post Certification If a protocol title was added to the esdl and certified by the PI, the protocol title cannot be removed from the system. In order to document the error, an end date should be added the protocol title and the end date should be the same date as the start date. The error should be documented in the comment field prior to submitting for certification, explaining the circumstances. Adding New Tasks to a Member To add a new task to a member: From the Associated Protocols portlet, select a protocol name by clicking on the check mark box on the left hand side: Page 24 of 54

Step 2. Navigate to the Associated Tasks portlet. Under this portlet, select the addition sign: a. Once a protocol is selected, the tasks for the member can be entered in the Task Maintenance window b. If the addition sign is selected without selecting a protocol, an error message will appear: Page 25 of 54

Step 3. The Task Maintenance window will now appear. From this window, the studyspecific tasks and start dates can be selected: Page 26 of 54

d. To select a task, click the check box on the right hand side of the specific task. Multiple tasks can be selected: i. For sites with site-specific roles not found under Study Title, select Add Site Specific Title and manually enter role: Once a Site Specific Task has been entered and added, it will appear in the Selected Tasks menu: Page 27 of 54

ii. A list of all study tasks and their definitions is provided in Table 2. Table 2. Overview of Study Task Definitions Study Title AE Submission/Completion Collect/Process Specimens Complete Site Staff Training Drug Accountability Drug Dispensation* Drug Ordering General ecrf Completion Definition This task will give a member access to entering adverse events in the system for the specific protocol assigned. It will also allow a member to receive adverse event notifications, including AE submissions and severe adverse events after review by the medical monitor for the specific protocol assigned. For example, if a member has this task for TN07, they will receive all AE notifications for TN07. This task will delegate a member to collect and process sample collections for the specified protocol. There are no system roles assigned with this task. This task should be listed for any member who is responsible for training all members at the site for the specified protocol. There are no system roles assigned with this task. Drug accountability includes: study drug storage, handling, and documentation of administration, return and/or destruction of the drug. A drug accountability process should be initiated for any study that uses study-supplied drug. This task is not applicable to observational studies. There are no system roles assigned with this task. A member with this task is delegated to dispense investigational drug when prescribed by the PI. This task is not applicable to observational studies. There are no system roles assigned with this task. All members who are responsible for ordering study drug must have this task. This task is not applicable to observational studies. There are no system roles assigned with this task. This task will grant a member access to complete electronic case report forms (ecrfs) for a specific protocol. ecrfs include the electronic specimen collection forms and also the electronic site visit forms. A member will not be able to access any participant data without this task assigned. Page 28 of 54

Inclusion/Exclusion Assessment* IRB/Regulatory Submission Laboratory Contact Main Site Contact Negative/Rescreen Letter Contact Obtain Informed Consent* Obtain Medical History Order Supplies Perform Physical Exams* Receive Study Emails Referral Processor Regulatory Contact Review Specimen Results* Members assigned this task are responsible for assessing the inclusion and exclusion criteria for a protocol in order to confirm if a participant is eligible to enroll. Inclusion and exclusion criteria may include factors such as age, sex, race, ethnicity, type and stage of disease, the participant s previous treatment history, and the presence or absence (as in the case of the healthy or control participant) of other medical, psychosocial, or emotional conditions. There are no system roles assigned with this task. This task should be listed for any member who is responsible for regulatory submissions. There are no system roles assigned with this task. This task should be listed for any member who should receive announcements that relate to laboratory operations, for example Lab MOO amendments. This task will place the member on the Coordinator contacts list for the specified protocol. This task is also important as it will assign the roles in the system to receive IRB approval lapse notifications. This task is applicable only to TN01 and to North American sites. This task should be assigned to the member who would like to be the contact listed on the negative and rescreen letters that go out to participants. This task must be assigned to all members who are responsible for getting permission to perform study procedures prior to any study-related procedures occur. There are no system roles assigned with this task. This task is assigned to all members who are responsible for obtaining past medical history from a participant. There are no system roles assigned with this task. This task should be assigned to anyone who is responsible for ordering supplies on the Fisher Website. This task should be listed for all members who are responsible for evaluating a participant at study visits. There are no system roles assigned with this task. This task is required for a member to receive protocol-related emails for the specified protocol. For example, TN01 recruitment material announcements or supply updates. This task is applicable only to TN01 and to North American sites. This task should be given to a member who is responsible for accessing the referral application when a referral comes in from the public website. This task should be listed for any member who should receive announcements that relate to regulatory, for example protocol or consent amendments. This task should be listed for any member responsible for reviewing and assessing all specimen results. There are no system roles assigned with this task. Page 29 of 54

Ship Specimens Source Documentation Completion Site Specific Task This task is delegated to all members responsible for physically shipping specimens to the central laboratories. There are no system roles assigned with this task. This task should be listed for all members responsible for completing source documentation for the specified protocol. There are no system roles assigned with this task. A site-specific task should only be manually entered if no other task listed on the Selected Tasks menu is acceptable. There are no system roles assigned with this task. Please Note: These tasks may only be performed by qualified individual as permitted by local law, medical or standard of care practices, or applicable required training as per job description or designation. e. To select the study title, select the calendar icon on the right hand sand and select the appropriate start date: Please note: A start date cannot be more than one day in the future. If a future date is selected, and error message will appear: Page 30 of 54

Step 4. Select Add/Update to add new task(s) to the member. Select Cancel to cancel addition: Once any tasks have been added for a member, the assigned tasks will now appear in the Associated Tasks portlet when the member and protocol are is selected from the Members at Site portlet and the Associated Protocols portlet, respectively: Removing a Task Added in Error Prior to Certification A task may be removed from the Associated Tasks portlet only if the esdl change has not yet been certified. If a task was erroneously added to a member on the esdl: From the Associated Tasks portlet, select the delete sign on the right hand side of the task that should be removed: Page 31 of 54

Step 2. A window will appear, confirming the request: Once the request has been confirmed, the task will no longer show under the Associated Tasks portlet. Post Certification If a task was added to the esdl and certified, the task cannot be removed from the system. In order to document the error, an end date should be added the task and the end date should be the same date as the start date. The error should be documented in the comment field prior to submitting for certification, explaining the circumstances. Adding End Dates to Protocol Titles An end date should be added to a member when they are no longer participating on the specified protocol or if the protocol is no longer active. To add an end date to a protocol title: From the Members at Site portlet, select the member that needs to be updated: Page 32 of 54

From the Associated Protocols portlet, select the check mark box on the left hand side of the protocol that needs to be updated: Step 3. Select the edit symbol on the right hand side of the protocol: Step 4. Select the appropriate end date from the Protocol Maintenance window: Page 33 of 54

Step 5. Select Add/Update to remove the protocol/title from the member. Select Cancel to cancel addition: Please note: Once an end date is added to the protocol tittle and the change is certified by the PI, all tasks associated with that protocol title will automatically populate end dates and remove all system roles. Adding End Dates to Tasks An end date should be added to a task when a member is no longer completing the task for the specified protocol. To add an end date to a protocol task: From the Associated Protocols portlet, select the check mark box on the left hand side of the protocol that needs to be updated: Page 34 of 54

Step 2. From the Associated Tasks portlet, select the edit symbol on the right hand side of the task: Step 3. Select the appropriate end date from the Task Maintenance window: Page 35 of 54

Step 4. Select Add/Update to end the task for the member. Select Cancel to cancel addition: Please note: Once an end date is added to the task and the change is certified by the PI, all system roles associated with that task will be removed for the member. Submit for Certification Once all changes have been made to the esdl, the member making the changes should submit the draft esdl. To submit the draft esdl for certification: From the Site Certification Status portlet, the member making the changes should enter brief comments about the requested changes: Please note: The comments field is not required to submit the esdl for certification. Page 36 of 54

Step 2. Select Submit for Site Certification : Step 3. A pop up window will appear, confirming a member would like to submit the draft of the esdl draft to the site PI: Step 4. Once the draft esdl has been submitted for certification, a pop up window confirming submission will appear: Page 37 of 54

Submit for Certification When the changes have been submitted for certification, the PI will be notified via email. The email will include the link to certify the changes: The email will be sent to the site PI, the Primary Study Coordinator(s) title, and the member submitting the requested changes. The PI can also certify the changes from the Certify Electronic Site Delegation Log link under the My Site portlet: To certify the draft esdl, the PI will select either the certify esdl link located in the email request OR go to the link located on the TrialNet Members website. Page 38 of 54

From the esite Delegation Log Confirmation of Changes page, the requested member and protocol title changes will appear on the left hand side of the page and tasks for each member will appear on the right hand side of the page:. Once the PI has reviewed the changes to the esdl, the PI will have the option to add additional comments in the comments field and also reject or approve the changes: After selecting reject or approve, the certification page will show confirmation of the request: Page 39 of 54

If the changes were rejected, an email notification to the site PI, Primary Study Coordinator(s) title, and the member submitting the requested changes will receive a rejected confirmation email: Please note: If the PI rejected the changes, no changes will be made to the esdl. If the changes were approved, an email notification to the site PI, Primary Study Coordinator(s) title, and the member submitting the requested changes will receive an approved confirmation email: Please Note: If the PI approved the changes, all tasks associated with the change will be added or removed based on the start or end dates entered. The PI MUST certify the changes in order for the changes to take effect. Once the esdl is certified, the current view can be reviewed right away on the Current esdl View page, which is outlined in Section 5. Page 40 of 54

5. CURRENT esdl VIEW PAGE Overview The Current esdl View is a read-only page which allows a site to view the current version of the site-specific delegation log. The function of this page is to: List all members at a site, associated protocols, and associated tasks Grant Clinical Centers the ability to view members, study titles, and protocol tasks for affiliate sites Please Note: Members are not able to edit this page. Functionality A member can view all protocol titles and tasks listed for each member on the esdl: Page 41 of 54

1. Drop down will show site name. Clinical Centers also have access to view the esdl at each of their affiliate sites: 2. Drop down allows a site to select all protocols at a site or a specific protocol: Page 42 of 54

3. Once the search has completed, all members associated with the protocol(s) will show: 4. The tasks for each member will appear on the right hand side when the blue task link is selected for the member: 6. USER MAINTENANCE PAGE Overview The esdl Maintenance Page is an editable page which allows a site to add and make edits to members at a site. The function of this page where sites will be able to: Add a new member to the esdl Add a new member to website Deactivate a member from having access to the website Correct member information on website Page 43 of 54

Adding a New User to esdl Only If a member needs to be added to the esdl, but does not need access to the TrialNet Member s Website (for example to enter participant data), the member making additions should do the following from the User Maintenance page: Select New User : Enter the member s prefix, first name, middle initial, last name, suffix(es) and title: Please Note: Only the first name and last name are required fields. The institution will automatically default to the member s institution making the changes. Page 44 of 54

Select No if the member does not require access to the TrialNet Members Website: Select Add to add the member to the esdl: Once a member is added, the member will now appear on the esdl Maintenance page. Please Note: If a member is not granted access to the TrialNet Member s Website, they will not be able to log into the website. Adding a New User to esdl and TrialNet Member s Website If a member needs to be added to the esdl and needs access to the TrialNet Member s Website (for example to enter participant data), the member making additions should do the following from the User Maintenance page: Select New User : Page 45 of 54

Enter the member s prefix, first name, middle initial, last name, suffix(es) and title: Please Note: Only the first name and last name are required fields. The institution will automatically default to the member s institution making the changes. Select Yes if the member requires access to the TrialNet Members Website: Page 46 of 54

Additional fields will appear. Enter the member s department, address, city, state, country, postal code, primary phone number, secondary phone number, fax number, primary email, secondary email, and any additional comments: Please Note: Only the first name and last name are required fields. Select Add/Update to add the member to the esdl and to grant real-time access to the TrialNet Member s Website: Page 47 of 54

Once saved, a New User Email Notification will be sent to the new member. The member will be able to log into the website as soon as the log in credentials are received. The email will go to the member making the addition, the new member, and the Primary Study Coordinator at the Clinical Center (if applicable): Please Note: The member will not have any tasks in the esdl or roles assigned in the system until the esdl has been certified with the correct roles assigned. Correcting a User Sites have access to update all members information at their site from the User Maintenance page. To correct a member s information: Select Correct User : Page 48 of 54

Step 2. Search for the member s name that requires a correction using the first and last name: Please Note: The institution will automatically default to the member s institution making the changes. Step 3. Select Search : Step 4. Select the member that needs a correction: Page 49 of 54

Step 5. The member s current information will appear in the fields below. Edit the fields that require a change (for example an updated phone number): Step 6. Select Edit to confirm the changes: Step 7. A window will appear, confirming the change request was saved: Please Note: Only the information that requires editing should be changed. All other fields not changed will stay as originally entered in the fields. Page 50 of 54

Deactivating a User If a member is no longer performing tasks for the TrialNet grant and has access to the TrialNet Members Website, the member should no longer have access to the website. In order to remove website access, a member must be deactivated in the User Maintenance page. To remove a member from the website: Select Deactivate User : Search for the member s name that requires deactivation using the first and last name: Please Note: The institution will automatically default to the member s institution making the changes. Select Search : Page 51 of 54

Select the member that needs to be deactivated: The member s current information will appear in the fields below. Select Edit to confirm deactivation: Step 6. A window will appear, confirming the request: Step 7. Once the edit option is selected, the member will no longer have access to the website and will no longer appear in the TrialNet Members Website Directory. The member will still appear on the esdl and should not be removed from the log as this is a running list of all members who have ever worked on TrialNet Studies: Page 52 of 54

Please Note: Prior to deactivating a member, all study titles/tasks must first have an end date. If there is no end date, an error message will appear, requesting ends dates be added to all titles/permissions: 7. esdl REPORT Once the esdl is certified, an accessible hardcopy of the esdl can be retrieved form site-specific eregulatory (ereg) Binder. The esdl report will list all members at a site and each protocol, title, and task associated with the member: The esdl legend will post at the end of the esdl report: Page 53 of 54

Please Note: The ereg Binder can be accessed under the My Site portlet on the main page of the TrialNet Member s Website: Additional guidance on the ereg Binder can be found on the ereg User Manual. Page 54 of 54