When a new protocol application is started, the Staff & Access page is blank, with the exception of a non-study staff access record for the submitter. If the submitter wishes to be staffed to the study, clicking the ‘Add Submitter to Staff’ button at the top of the page will move the submitter’s record from the non-study staff access grid to the study staff grid. Each person must be assigned to a role in order to successfully complete the validation process. The submitter is a contact person by default, and therefore granted manage access to the protocol regardless of their role.
To begin the staffing process the user searches for staff in order to add to them to a protocol. The search can be by First Name, Last Name or Username. Multiple people can be selected from the search results grids (Study Staff and Non-Study Staff) and then moved to the selected results grid. Search results display Last Name, First Name, Username, and Organization (Institution / Department / Unit) of the person selected. A user can perform as many searches as needed to populate the ‘Selected Results’ list. The ‘Selected Results’ list will build continuously until the ‘Next’ button is selected.
If a person needs to be removed from the ‘Selected Results’ list, click the box in the ‘Remove’ column; and the person will not be included in the study list as the process of staffing continues. The staff is not added to the ‘Selected Results’, when you hit the Next button to assign permissions to the staff there will not be any records.
Additionally a search can be executed for external users who do not belong to the Partners network (do not have a username) but have affiliations in the system for prior studies they have been staffed too. There is a checkbox ‘Search Externals (Non Partners)’ on the search screen and, when checked, the searchable fields are Last Name and First Name; external people will not show up if this box has not been checked.
When clicking on the ‘Show Instructions’ link, instructions are available to help submitter through the process.
Screenshot 1: Begin Staffing Process
Screenshot 2: User has clicked the ‘add study staff’ button:
Screenshot 3: User has searched for a person and added that person to the ‘Selected Results’ grid:
Screenshot 4: User has clicked ‘Next’:
If an external person has not yet been added to the database, they can be added by providing required information when prompted.
Click on the ‘Yes’ radio button to add a new external person.
Click on the ‘No’ radio button to bypass this page and continue the staffing process.
Once added, the external study staff row will have a blank Username and Certification Date, a CITI Certified value of ‘No’, Contact Person will not be checked and the Organization will be populated with the Institutional Affiliation. External people do not have usernames and therefore will not have access to Insight.
Screenshot 5: User has clicked ‘Yes’ to adding external staff:
Screenshot 6: User has completed external staffing and clicks the “continue” button to proceed:
Screenshot 7: User has completed staffing and all entries are displayed:
Once study staff members have been added, the process cannot be completed until each study staff person is given a role. A role is selected by clicking on the ‘Edit’ link in the Action column of the Study staff grid. There can only be one staff member with the role of Principal Investigator. If the PI role is given to more than one staff member and error will appear on the page:
Click the “Save” action to save the changes to the staff row or ‘cancel’ to not save the changes. If ‘save’ or ‘cancel’ are not checked an error message will appear.
Note: Roles can only be edited for staff being added as part of a new process (for example during a new protocol or an amendment). This means that if an amendment is being added to an active protocol that requires a role to change, the person must be removed from the study and re-added with the correct role.
Click the Staff & Access tab
To add staff, click the “Add Study Staff” button.
Enter person information and click the “Search” button. For best results, try searching on user name or last/first name alone without entering institution/department, etc.
Note: if the person you want to add does not have a Partners user name, click the “Next” button at the bottom of the screen and skip to step 15.
In the Search Results, check the box next to the name of the correct person and click the “Add to Selected Results” button.
Repeat the steps above until all staff are in the ‘Selected Results’ grid. When complete, click the “Next” button
If there are staff that do not have a Partners user name, or collaborators that will be working independently from their non-Partners institutional/academic appointment as part of the study, then answer ‘Yes’ to the next question, “Do you need to add any people that do not belong to a Partners Institution that you did not find in the search results?” and complete the form for each of those staff. If not, then click the “Continue” button.
You are then brought back to the ‘Staff & Access’ main screen. Find the row with the name of the person you just added. In the ‘Action’ column of that row, click the ‘Edit’ link.
Select a study related role from the ‘Role’ pull down as close to the person’s actual study responsibilities.
Indicate if the person should receive IRB correspondence by checking the ‘Contact Person’ check box.
Select the person’s permission for the protocol record- View=read only; Edit=can make form changes; Manage=can change other’s permissions.
When complete, click the ‘Save’ link at the end of the row. Repeat for all people added.
If any of the added study staff must be deleted, find the row with the name of the person you need to remove. In the ‘Action’ column of that row, click the ‘Edit’ link, check the “Remove” checkbox and click the “Save” link.
Click the ‘Submission’ tab
Click the “Run Application Review” button to validate that all required fields contain data.
If there are no errors, click the “Submit” button. If there are errors, click the error description to be brought to the form to correct the error.
Once you click the "Submit” button, the submission is automatically routed for electronic sign off. You can track the progress of the sign off process by going to the Pending Applications page and clicking on the Workflow History icon in the row where the transaction appears.