New Protocol - expedited & full board

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1 New Protocol - expedited & full board training guide 2015, The Trustees of Indiana University KC IRB Training Guide: New Protocol - Expedited & Full Board 1

2 table of contents Table of Contents 2 table of contents 3 about this guide 4 Protocol tab 9 Personnel tab Hyperlinks The Table of Contents text has active hyperlinks. Click to jump to any page in this document. 14 Permissions tab 16 Questionnaire 17 Notes and attachments 22 Protocol actions tab 24 Post Submissions actions 25 additional information return to the table of contents button There is a return button at the bottom of every page to help you return to the Table of Contents. KC IRB Training Guide: New Protocol - Expedited & Full Board 2

3 about this document About this Document this document provides: The instructions for creating and submitting a new Expedited or Full Board protocol. KC IRB Training Guide: New Protocol - Expedited & Full Board 3

4 Protocol tab KC IRB Protocol > Protocol Tab > Required Fields for Saving Document 1. required fields for Saving document folder. Enter: a. Protocol type = Select expedited or full board b. title c. Principal investigator i. Click for iu user id Search and search for PI 1. If known, enter username (this is the fastest search) a. If unknown, search by another value, such as Last Name, using an * (e.g., Johnson*). 2. Click search 3. Click return value link ii. If the PI does not have an IU User ID, he/she must obtain one before the study can be submitted. Please review the Quick Reference Guide - Accessing KC IRB for instructions on requesting an IU computing account. d. The PI s lead unit should automatically populate. i. If it doesn t or to change it to the unit associated with this research, click to search for a different unit or type the Unit Number (e.g., IN-PHEM) directly in the field. KC IRB Training Guide: New Protocol - Expedited & Full Board 4

5 Protocol tab KC IRB Protocol > Protocol Tab e. Click the save button at the bottom of the page under the list of folders. You may wish to make note of the Protocol #, located at the top of the page in the document header area, or in the Status & Dates folder. i. If you want to return to the protocol for future completion and submission, you may click the close button at the bottom of the page under the list of folders. ii. You will be asked, Would you like to save this document before you close it? iii. Click the yes button 2. For Full Board studies only, click show on the Additional Information folder. a. Enter IND or IDE #, if applicable; if none, leave blank. If multiple INDs/IDEs, separate with semicolon. b. If there is an IND/IDE, in the IU or Investigator held IND/IDE field, enter Y or N. KC IRB Training Guide: New Protocol - Expedited & Full Board 5

6 Protocol tab KC IRB Protocol > Protocol Tab 3. Organizations folder a.click for Organization Lookup and search for all sites at which the research will be conducted. i. The Organization Type field defaults to Frequently Used in IRB and will automatically return a list of commonly used organizations. ii. If your organization(s) doesn t appear in the list, change the Organization Type in the drop-down menu to select and use the search fields to enter criteria; click search. A. Click on the under Organization Name to sort the list alphabetically. B. To choose an organization(s), click in the box next to the appropriate name(s) under the Select? Column and click return selected. C. If you are still unable to locate at least one organization where your research will be conducted, select Indiana University to enter for the Organizations Tab, and list the other organization(s) on the Sites & Collaborations Questionnaire. iii. If you are able to find some but not all your Organizations, enter the ones you are able to locate for the Organizations Tab, and list the other organization(s) on the Sites & Collaborations Questionnaire. iv. To remove an organization, click delete organization under Actions. KC IRB Training Guide: New Protocol - Expedited & Full Board 6

7 Protocol tab KC IRB Protocol > Protocol Tab > Funding Sources 4. Click show on the funding Sources folder. a. Select funding type see chart on the next page b. Enter funding Number see chart on the next page c. Enter Source see chart on the next page d. Click add button KC IRB Training Guide: New Protocol - Expedited & Full Board 7

8 Protocol tab KC IRB Protocol > Protocol Tab T YPE OF FUNDING* ChOOSE Th I S FU NDING T YPE I N (KC)* FUNDING NUMBER (KC) SOURCE (KC) TITLE Grant or Award negotiated by IU Grants & Contracts (federal, federal pass-through, state, notfor-profit, or industry sponsor) Institutional Proposal Use a lookup to link the IRB protocol to the funding proposal in KC Grants system N/A Will auto-populate once Funding Number is populated Industry Sponsor (not negotiated by IU Grants & Contracts Office) Sponsor Use a lookup to select appropriate Sponsor name Will populate with Sponsor name once selected in the lookup N/A IU Department or Academic Unit (internally funded) Unit Use a lookup to select appropriate Unit name Will populate with Unit name once selected in the lookup N/A No funding Unfunded N/A N/A N/A Other None Free-text date funding received Free-text source of funding N/A *Note: Do not use Funding Type of award or development Proposal. 5. The Participant types folder defaults to an open view a. Type total will be displayed b. Enter the maximum number of participants/records/specimens to be included in the research under count c. Click add d. Review the other Participant types that may apply to the research, and select any applicable Type from the drop down menu i. Optional: If known, or part of the study design, enter the count in the textbox (number of each participant type expected to be involved in the research) e. Click add f. Repeat above steps until all participant types to be involved in the research are listed. 6. Click save 7. Make note of the Protocol #, located at the top of the page or on the Status & dates folder, and enter this on all the forms and study documents (Refer to the Human Subjects Office Website for a list of the required documents for a Full Board or Expedited protocol). KC IRB Training Guide: New Protocol - Expedited & Full Board 8

9 Personnel tab KC IRB Protocol > Personnel Tab > IU User ID 1. The Principal Investigator who was selected in the Protocol tab will be displayed in a folder in the Personnel tab. 2. To add study personnel: a. Search for individuals using IU User ID first, even if you think the individual may not have an IU username. Click to search for an iu user id (includes IU students, faculty, affiliates, etc.). i. If known, enter username (this is the fastest search) ii. If unknown, search by another value, such as Last Name, using an * (e.g., Johnson*). iii. Click search iv. Click return value link KC IRB Training Guide: New Protocol - Expedited & Full Board 9

10 Personnel tab KC IRB Protocol > Personnel Tab > No IU User ID Search b. If you do not find the person via IU User ID, search by clicking next to No iu user id Search. a. If known, enter username (this is the fastest search) b. If unknown, search by another value, such as Last Name, using an * (e.g., Johnson*). c. Click search d. Click return value link c. If you do not find the person via No IU User ID Search, please refer to the Quick Reference Guide Accessing & Creating a New Rolodex Entry. d. When value is returned, select the appropriate Protocol role from the drop-down list and click add person. Note: Co-PI Student/Fellow/Resident role should only be selected for student-directed projects to list the student investigator. 3. Click show on the person s folder, then click show on Person details tab. a. Confirm Protocol Role. If an incorrect role was previously selected, choose the appropriate role from the drop-down and click b. Select Affiliation Type i. If the individual is an IU faculty member, staff, or student, or has an IU username, choose IU. ii. If the individual is not IU an faculty member, staff, or student and does not have an IU username, but is a member of an institution which utilizes the IU IRBs (e.g. IU health, Wishard/Eskenazi health, Regenstrief, Roudebush VAMC), choose Affiliated. iii. If the individual is not affiliated with IU or an institution which utilizes the IU IRBs (see above), choose Non-Affiliated. 4. lead unit should automatically populate under the unit details section of the Principal investigator s section. KC IRB Training Guide: New Protocol - Expedited & Full Board 10

11 Personnel tab KC IRB Protocol > Personnel Tab > Unit Details 5. unit details will also automatically populate for any Investigator with an IU username. a. If it doesn t or to change it, click show on unit details subsection and click to search for a different unit. b. Click return value link c. Investigators may be associated with multiple units, but only one may be selected as lead unit per protocol. 6. Repeat steps to add study personnel until all are listed. Note that the same person cannot be listed twice, with two different personnel roles. 7. Click save. 8. If an error was made and an investigator entry needs to be removed, click within the checkbox Sullivan, Vi c th at appears at the left of the person s folder label to select the item(s). A check mark appears within the checkbox to indicate the item is selected. Click within the checkbox again to clear the mark if you want to deselect the item. a. Click the delete selected button at bottom of page. delete selected KC IRB Training Guide: New Protocol - Expedited & Full Board 11

12 Personnel tab Viewing Investigator Requirements Investigators who still need to complete a requirement will be highlighted red with an X. Investigators who have completed both requirements will be highlighted green with a check mark. Investigators without an IU username will display in black text Viewing investigator requirements The Personnel tab allows users to see whether investigators have completed the COI and CITI requirements at one glance. All investigators must complete applicable requirements before this submission can be approved. KC IRB Training Guide: New Protocol - Expedited & Full Board 12

13 Personnel tab KC IRB Protocol > Personnel Tab > Conflicts of Interest 9. The Conflicts of Interest folder will automatically open. a. Respond to all questions. Note: for additional help or explanation, click More Information... to the right of the question. b. Click save to review your responses or click Permissions tab (e-doc will automatically save when moving to a new tab). KC IRB Training Guide: New Protocol - Expedited & Full Board 13

14 Permissions tab KC IRB Protocol > Permissions Tab > Assigned Roles Study personnel are automatically assigned certain permissions based on the protocol role assigned to them on the Personnel tab. For more information about automatic permissions, please see the Quick Reference Guide Permissions. If individuals who are not a part of the study team need to view protocol information, make submissions or request IRB actions, or receive protocol notifications (approvals, renewal reminders, etc), they must be designated as a Study Manager/correspondent on the Permissions tab. KC IRB Training Guide: New Protocol - Expedited & Full Board 14

15 Permissions tab KC IRB Protocol > Permissions Tab > Users 1. In Users section: a. If you know the individual s IU user name, enter it into the box in the user Name column. Skip to instruction 2 below b. To search for an individual, click on the button in the user Name column. i. Click clear to remove the home Unit. ii. Search using the criteria available; last name or address returns the best results. If only part of an address or last name is known, you may enter * as a substitute for unknown letters. For example, if searching Smithwick, you could enter Smith* to return the same results. iii. Click Search. iv. Click the return value link associated with the appropriate person. 2. Click the drop-down button under Role and select Study Manager/Correspondent. DO NOT select Viewer, Aggregator, or Protocol Deleter. 3. Click add. Note: Study contacts must have an IU User ID in order to be listed as a Study Manager/Correspondent. Please review the Quick Reference Guide - Accessing KC IRB for instructions on requesting an IU computing account. To remove a Study Manager/Correspondent: 1. Select the delete button under actions. 2. A question will appear: Are you sure you want to delete xxx, xxx xxx from the list of users? a. Click yes. KC IRB Training Guide: New Protocol - Expedited & Full Board 15

16 Questionnaire tab KC IRB Protocol > Questionnaire Tab Much of the information for a new Expedited or Full Board study application will be housed directly in the KC IRB system on the Questionnaire Tab. Questionnaires function as smart forms, so as you answer questions additional questions or Questionnaire folders will be displayed based on responses you provide. Only supporting documents (such as consent/assent/authorization documents, survey questions, recruitment materials, etc) will need to be added to the Notes & Attachments Tab. 1. The required Questionnaires for this study will populate on this tab automatically, based on your answers on the Protocol tab. 2. Click to open an individual Questionnaire folder and complete the questions. a. Depending on the specific question and your answer, additional questions may appear and other questions that don t apply may disappear. For example, checking No to the question Does any research activity in this study present more than minimal risk to human subjects will open additional questions regarding Expedited Categories of research. 3. Click at the end of each Questionnaire to save changes. When all required questions have been answered, the individual Questionnaire tabs will change from (Incomplete) to (Complete). KC IRB Training Guide: New Protocol - Expedited & Full Board 16

17 Notes and attachments tab KC IRB Protocol > Notes and Attachments Tab > Protocol Attachment 1. Click on the Notes & attachments tab. 2. Click show on Protocol attachments folder to attach the required study documents (Refer to the Human Subjects Office Website for a list of the required documents for an Expedited or Full Board protocol). a. Select an attachment type from drop-down list. b. Status will default to Complete. If additional changes are needed, and you wish to store a copy here for update at a later time, select Incomplete; note that you will not be able to submit the protocol until all attachments have a status of complete. c. Enter a Description that will help you identify the document. It is recommended that you include a version date or number within the description. For example, Consent form healthy controls v KC IRB Training Guide: New Protocol - Expedited & Full Board 17

18 Notes and attachments tab KC IRB Protocol > Notes and Attachments Tab > Protocol Attachments d. Other fields which can be completed if needed, though not required for saving, are contact Name, , Phone, and comments. e. To add an attachment, click browse for file Name search. i. Locate the file and click open to attach. Note: all commonly used file types should be compatible except for.msg (outlook messages) f. When file returns, click add. 3. Repeat above steps for each attachment. 4. upload Zip documents Several attachments can be uploaded with one click. Use the Upload Zip button which will upload all documents from a zip file identified by the user. Once documents are uploaded, users simply need to update the Attachment Type and Description for each document, and then save. KC IRB Training Guide: New Protocol - Expedited & Full Board 18

19 Notes and attachments tab KC IRB Protocol > Notes and Attachments Tab > Protocol Attachments 4. Once an item is attached, it is listed under attached items; details can be seen by clicking the show button. 5. Click on the show button of an attachment to: view, replace, or delete. a. To view an attachment, click on view i. A popup window will appear; Select Save or Open to view the file. b. To replace an attachment, click on replace. i. This removes the attachment and you can browse for a new file Name. ii. Locate the file and click open to attach. c. To delete an attachment, click on the delete. i. A question will appear: Are you sure you would like to delete the following attachment: XXXXX? ii. Click yes or no KC IRB Training Guide: New Protocol - Expedited & Full Board 19

20 Notes and attachments tab KC IRB Protocol > Notes and Attachments Tab > Notes 6. The number of Protocol attachments is indicated on the folder label in parentheses. 7. To add a Note, enter a Note topic and Note text. a. Click add under actions. This note will be visible to all persons with access to view the protocol. b. Click save c. To edit or remove a note, click the edit or delete button under actions. Once a note has been added, it can be deleted by persons with the Aggregator role on the protocol up until it is submitted to the IRB. Other personnel can view the notes. d. The number of Notes is indicated on the folder label in parentheses. KC IRB Training Guide: New Protocol - Expedited & Full Board 20

21 custom data & Medusa tabs KC IRB Protocol > Custom Data & Medusa Tabs 1. The Custom Data Tab is for Human Subjects Office staff use only. Investigators cannot enter or change any information here. 2. The Medusa Tab allows cross-reference to other e-docs within KC; no action on this tab is required by investigators for IRB submission. KC IRB Training Guide: New Protocol - Expedited & Full Board 21

22 Protocol actions tab KC IRB Protocol > Protocol Actions Tab > Request an Action > Submit for Review 1. Click on the Protocol Actions tab 2. Click show on the request an action folder. 3. Click show next to Submit for review. 4. Select Submission type of initial Protocol application from the drop down list. i. For Expedited studies, the Expedited Categories Checklist will appear. Select all appropriate Categories. 5. Select Submission Review type of full board or expedited. 6. Do not select a Type Qualifier. 7. Click submit KC IRB Training Guide: New Protocol - Expedited & Full Board 22

23 Protocol actions tab KC IRB Protocol > Protocol Actions Tab > Data Validation 8. KC IRB will validate some of the information entered (e.g. check for empty fields, required responses, investigator training, etc.) and may return an error or warning message at the top of the page, above the folders. a. If this happens, the data Validation folder will expand. b. The system will return any validation errors, warnings, unit business rules errors, and unit business rules warnings. c. To correct any errors or address any warnings, click on the link provided (fix button on the right hand side), which will allow you to navigate to the portion of the document containing the error where you can view messages and make corrections. 9. Once there are no validation errors present, repeat steps above to submit the protocol for review. 10. The following message will be returned: KC IRB Training Guide: New Protocol - Expedited & Full Board 23

24 Post Submission action Post Submission Action Once a protocol has been submitted, if you need to make changes to or withdraw the submission, please contact the human Subjects Office at irb@iu.edu, referencing your KC IRB protocol number. KC IRB Training Guide: New Protocol - Expedited & Full Board 24

25 additional information about Kc irb Kc irb training guides and training Videos. Additional Training Guides and Training Videos can be found at the Indiana University Office of Research Administration website. KC IRB Training Guide: New Protocol - Expedited & Full Board 25