Research Team Personnel
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- Griffin Dennis
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1 Research Team Personnel Individuals involved in the following activities should be named on the protocol application: Recruitment Obtaining consent Collecting data Analyzing data If there is uncertainty as to the role of a person and whether or not the person needs to be identified/named on the protocol application, please contact the Office of Research Compliance for guidance. Uncc irb@uncc.edu or or There are different procedures for adding individuals affiliated with UNC Charlotte and adding individuals not affiliated with UNC Charlotte. Project Personnel are added in the General Information section of the protocol application. Personnel are added one by one and a role assigned to each individual. Choose Click here to add personnel link. The Investigator must add him/herself to the protocol applicatin. 1
2 This will result in a personnel table. This initial step is followed for all personnel, including those not affiliated with UNC Charlotte. NOTE: DO NOT MANUALLY ADD INDIVIDUAL INFORMATION TO THE TABLE FROM THIS SCREEN 2
3 For individuals affiliated with UNC Charlotte: Click the magnifying glass icon or put the cursor in the text box to activate the search option to search UNC Charlotte directories (data are populated daily from Banner). Search by Last Name or PID if this number is known to you. Choose the correct UNC Charlotte individual from the resulting search results. 3
4 The person s information will automatically populate the initial personnel table. Choose the appropriate Role for the person and then Save the personnel record to complete the procedure for adding this person to the protocol application. As you add personnel, you will need to designate a Liaison. This person serves as the point of contact for questions related to the study or study site for multi site studies. This may be someone other than the Principal Investigator. 4
5 For individuals NOT affiliated with UNC Charlotte: Independent Investigators Persons who will collaborate with limited involvement in the study, the study is not a multi site study, and/or the person is involved in the research in an unaffiliated capacity (not an institutional capacity) may be may be named on the protocol as Independent Investigators. Click the magnifying glass icon or put the cursor in the text box to activate the search option to search UNC Charlotte directories (data are populated daily from Banner). Click the Person Not Listed link to generate the appropriate personnel table to manually add unaffiliated persons. 5
6 Manually enter the person s name and contact information. The person s affiliation may also be manually entered in the Department Name field and NOT in the External Institution field (i.e., leave the External Institution field empty/blank). Click the Submit button. 6
7 The manually entered information will populate the initial personnel screen. Confirm that the Independent Investigator box is checked and the person s Role on the research team is identified. Save the personnel listing. The saved personnel listing will appear in the protocol as an Independent Investigator. 7
8 For individuals NOT affiliated with UNC Charlotte: External Institutions ONLY add External Institutions if this is a multi site study and the external institutions will rely on the UNC Charlotte IRB for review and oversight of the study at all institutions (multi site). ONLY use the External Institutions search (magnifying glass) to add a collaborator if UNC Charlotte will enter into an IRB Authorization Agreement/Reliance Agreement with the collaborator s IRB. If there is any question as to applicability of such an agreement Office of Research Compliance for guidance. Uncc irb@uncc.edu or or NOTE: If an External Institution will be named on the protocol, the Screening Question #4 must be a YES response. IRBIS will prompt you to update this Screening Question if you attempt to add personnel as using External Institutions. 8
9 You may manually add persons. Use the External Institution search (magnifying glass) to add a collaborator IF UNC Charlotte will enter into an IRB Authorization Agreement/Reliance Agreement with the collaborator s IRB. This may be applicable if this is a multi site study. The External Institution Listing search will activate so that you may search for the collaborating institution. 9
10 Select the appropriate institution to populate the External Institution field. The available Role for the unaffiliated person is limited to External Site PI. Complete the remainder of the table and Submit. The manually added External Institution and PI will populate the initial personnel screen. A Liaison for the External Institution must be designated. Confirm that the Liaison item is completed. Save the personnel listing. 10
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