FIELDS REQUIRED TO SAVE A PROTOCOL

Transcription

1 Human Subject Research Protocols If conducting human subject research, a protocol must be submitted in WVU+kc to the WVU Institutional Review Board for review. Click on the Create IRB Protocol link located in the IRB menu bar of the dashboard. FIELDS REQUIRED TO SAVE A PROTOCOL The Protocol page collects general information about each protocol. Once all required fields have been completed, click the save button or navigate to the next page to complete the other pages of the protocol. Description is the only required field located within the Document Overview section and the text entered into this field should be the short-title of the specific protocol. The description entered is useful when conducting a Document search within WVU+kc. This field has a 40-character limit. Protocol Type is the anticipated level of review the protocol will likely require; keep in mind, the final determination will be made by ORIC. This selection will also determine what sections you will be required to answer on the Questionnaire page of the protocol document. Selecting the incorrect review type may result in you providing too much or not enough information about your protocol. Protocol type options include NHSR, Exempt, Full Board, Clinical Trials (External Protocols), Central IRB, Emergency Use, Expedited, and HUD. The full Title of the project should be entered in this field, which has a 2000-character limit. Indicate the person who will have absolute responsibility for the overall conduct of the research in the Principal Investigator field. Select the Lead Unit (Department) that is the primary home of the PI on the protocol. Additional Information There are various fields located on the Protocol page that although not required, ORIC prefers that they be completed, if the information is available. ECOG, RTOG, COG, etc. numbers can be attached to the protocol in the Additional Information section. NOTE: If submitting a Clinical Trial protocol, you will be required to enter at least one Other Identifier. Keywords One or more keywords must be selected for the protocol to identify the primary focus of the study. it.wvu.edu/services/training/wvu-kc/kc-irb-protocol Last Updated October 2016

2 ADD PERSONNEL The Personnel Page is where the individuals involved on the protocol will be specified. The Principal Investigator who was added on the Protocol page will display in an expandable folder on the Personnel page. To add other personnel: Conduct a search by clicking on the WVU Employee/Student Search. Search by first or last name or conduct a wildcard search by using an asterisk (*). Once the appropriate person has been identified in the search results, add the person to the protocol by clicking Return Value. Add the person s role from the drop-down list in the Protocol Role field. Add the person to the protocol by clicking the add person button. Person Details A tabbed person detail section will populate for every person added to a protocol. Click the show button to display the subsections: Person Details displays the role that was selected when the person was added to the protocol. This role can be modified by clicking on the drop-down menu and selecting a new role in the Protocol Role field. A summary of PI Qualifications must be provided for all PIs. The qualifications should be a few sentences stating the PI s current position at WVU, years of experience, and any previous experience in the particular research field. To delete a person, select the checkbox in the Detail Section and click the delete selected button at the bottom of the page. Non-WVU Personnel There are two options for adding non-wvu team members: Non-Employee Needs Access to WVU+kc. First search to see if the person is already in the WVU Identity and Access Management database by clicking the WVU Employee/Student search. If the person does not show up in the search, a special WVU Login account request must be made. Submit this request via the online WVU Login Special Account Request and be prepared to provide the following information for the person: first and last name, person s birth date, title that describes the person s role on the project, and system access start and end dates. it.wvu.edu/services/training/wvu-kc/kc-irb-protocol 2 Last Updated October 2016

3 Non-Employee Does Not Need Access to WVU+kc. Search the Non-WVU Person Search to see if the person has already been added to that database. If the person does not show up in the search, click on the link to add a new Rolodex entry into the WVU+kc Address Book. Add the person s name and address and click the submit button to add. Once in the non-employee database, the person will remain in the database for future nonemployee searches. PERMISSIONS The Permissions page can be used to assign specific roles to people. The Assigned Roles section will display all of the people who currently have rights to either view or edit the protocol and their corresponding role. Aggregators are given the ability to edit a protocol, while viewers are given view-access only. To edit the permissions for someone already on the protocol, click the edit role button for that person in the Users section. Select the checkbox for the role the person should have and click the save button. To add a new person click on the search icon in the User Name field to search for the person. Return the value of the desired person, select the appropriate role and click the add button. To delete a role, click the delete button for the appropriate user and confirm that the person should be removed by clicking the yes button. NOTE: After adding a user, editing a role, or deleting a role, it may be necessary to click the reload button at the bottom of the page in order for the changes to show in the Assigned Roles section. PROTOCOL DETAILS The Questionnaire page is where you will enter the bulk of the information for the protocol. All required sections will display based upon the protocol type selected on the Protocol page. Once the questions within the section are successfully completed, the header will turn green and indicate that it is (Complete). Business rules embedded can cause additional questions to appear in response to the answers to particular questions. Click the save button at the bottom of the page to save answer selections and text entries. Clicking the save button will save an incomplete Questionnaire, change the section header from (Incomplete) to (Complete) and allow you to finish it later. You will have the ability to modify previous responses as desired within a saved protocol that has not been submitted for review. The expand all button will expand all sections on the page to display all questions that need to be completed. An individual section can be expanded by clicking on the show button. The collapse all button will compress all sections on the page. An individual section can be collapsed by clicking the hide button for it. it.wvu.edu/services/training/wvu-kc/kc-irb-protocol 3 Last Updated October 2016

4 Questionnaire Updates From time to time, there will be updates made to the Questionnaire page. A validation error will display on the Protocol Actions page indicating that the Questionnaire needs to be updated. Navigate to the Questionnaire page to update the sections before you can submit your amendment/renewal. There are two options to update a section. The default selection is to copy the existing answers. If you are making significant changes to a section and do not want to copy the current answers, select Do not copy answers from my previous questionnaire. After making the appropriate selection, click the update button located on the right side of the section. For more information about Questionnaire updates, see IRB Protocol Questionnaire Updates. ATTACHMENTS Attachments related to protocols can be uploaded to a protocol on the Notes & Attachments Page. Users are able to specify the type of attachment and describe it. Any type of document or file format is supported, but there is a 50 MB size limit. UPLOAD ATTACHMENTS Throughout the course of completing the Questionnaire page, a question may have indicated the need to attach additional documents, such as a HIPAA Waiver of Research form or an IRB Authorization Agreement. To attach a document to the protocol: Click on the Upload button located in the Add Protocol Attachment section. From your desktop, drag and drop the files, or a folder of documents you need to add, or click on the Upload a file button to select the files you need to add. All attachments that are ready to upload will be listed in the Add Protocol Attachments section. Once you have added all pertinent attachments, click the Finished button to finalize upload. it.wvu.edu/services/training/wvu-kc/kc-irb-protocol 4 Last Updated October 2016

5 ATTACHED ITEMS The documents that you uploaded will now be displayed in the Attached Items section. Open each file to select the Attachment Type, Status, and enter a Description for each file uploaded. All three of these fields must be completed before you can submit your protocol. NOTES Notes can be added to correspond with departmental administrators or the ORIC but are not required. If entering a note, you must enter a topic and descriptive text, then click the add button to add the note. A time stamp with the date and author of the note will display upon save of the page. NOTE: After a protocol has been submitted, any previously-entered notes will become read-only and cannot be edited or deleted unless submitting an amendment/renewal to the protocol. SUBMIT PROTOCOL Navigate to the Protocol Actions page in order to submit a protocol, whether it be a new submission or to submit a renewal/amendment. Actions available to you will display in the Request an Action section depending on the status of your protocol. Select the Submission Type under Submit for Review and click the submit button to submit the protocol, amendment or renewal. OTHER ACTIONS Print. From the Protocol Actions page, open the Print section. Select the areas of the protocol that need to be printed and click the print selected button to print to pdf. Copy. From the Protocol Actions page, open the Copy to New Document section. Click the copy protocol button to copy the protocol to a new document. Protocol Status. From the Protocol Actions page, open the Route Log. Any actions currently pending on the protocol will display in the Pending Action Requests section along with the name of the person of which the action is being requested. Any actions required after the current pending action will be displayed in the Future Action Requests section along with the name of the person of which the action is being requested. Correspondence. From the Protocol Actions page, open the Correspondence section to view any correspondence that has been generated associated with the protocol including approval letters and revision requests. Summary. Navigate to the Protocol Summary page to see a summary of the current version of the protocol. Protocol History. From the Protocol History Page, open the History section to see the list of actions that have been completed on the protocol and the dates these actions were completed. it.wvu.edu/services/training/wvu-kc/kc-irb-protocol 5 Last Updated October 2016