era(infoed) Electronic Submission Instructions and Tips: Initial Application

Transcription

1 era(infoed) Electronic Submission Instructions and Tips: Initial Application This instructional document introduces users to submitting NEW research protocols electronically through the era(infoed) system. Make sure you know whether your project requires EXEMPT, EXPEDITED, or FULL BOARD REVIEW. Visit our step-by-step guide for more information. Before you can submit documents electronically, you should first review the following required elements to gain era(infoed) access. The era(infoed) website is where the COMIRB database and electronic submission website is housed. If you are an Employee of the University of Colorado Denver, you have the ability to log into this website using your CU Denver employee login information. If, however, you are a researcher or staff member at a CU Denver Affiliate Site, user access to the era/infoed) website requires Person of Interest (POI) Number. Follow the instructions for obtaining access to the COMIRB era(infoed) data system and completing other tasks necessary to start or join a COMIRB study. Important Note On Study Access: Access to studies on era(infoed) that are In Development is limited to the individuals listed on the study until its approval. This means only study personnel listed on the PERSONNEL FORM can edit or access the study prior to its submission to COMIRB. If you are a coordinator working on a submission on behalf of your PI, make sure to complete the Personnel Form (Step 3.E. below) before exiting the submission to ensure that everyone has the necessary access. STEP 1: LOGIN INTO ERA(INFOED) A. Navigate to in your preferred Internet browser. B. Enter your POI or CU Denver username and password. Select DENVER as the Campus. C. Click the SIGN IN button. STEP 2: Create A NEW PROTOCOL A. Select MY HUMAN SUBJECTS TAB from the menu located on the lefthand side of your browser window. B. Click the CREATE NEW and a new window will open. C. Click the CONTINUE BUTTON. 1

2 D. Enter the protocol title and click the CONTINUE BUTTON. E. Select a PRINCIPAL INVESTIGATOR. Your name should appear in the field. To select someone else as the PI, delete your name from the field, then begin typing their name in the field in the format Last Name, First Name (e.g. Smith, John). There may be multiple listings for the same person. Please select the one with the relevant department after the name for the research being conducted. F. Click the CONTINUE BUTTON, refreshing the window to the INITIAL APPLICATION screen. Please note: once this screen refreshes, era(infoed) assigns your protocol number automatically. The number can be viewed in the upper left-hand corner of the screen. This is what the INITIAL APPLICATION screen looks like: 2

3 STEP 3: COMPLETE THE INITIAL APPLICATION SUBMISSION COMPONENTS Last Updated: December 15, 14 The INITIAL APPLICATION SCREEN serves as the workspace for uploading not only the required elements that must be completed with each study submission, but also all relevant supporting documentation depending on the type of review. Please make sure to maintain electronic copies of all submitted documents. Below are links to the 6 steps required to submit a study for COMIRB review: you will find the links included again after each step in the process: A. Edit the required Routing (eform) B. Download, edit, and upload the Application for Protocol Review C. Download, edit, and upload the Protocol (not needed for Exempt/Non-human Subjects Submissions) D. Determine which supporting documents are needed for the review submission E. Complete the Personnel Form (eform) F. PI Attestation Form G. Submit to COMIRB 3

4 A. ROUTING FORM To Edit the Routing Form: i. Click on the linked name of the ROUTING (EFORM) to open the routing form in a new browser window. ii. Select if you are submitting to CIRB, then choose the type of REVIEW being requested (Exempt/Expedited/Full Board) from the drop-down menu under heading labeled TYPE OF SUBMISSION. The Routing Form generates questions based on answers; if FULL BOARD is selected, then you will be prompted to answer a series of questions directing you to the appropriate panel. iii. If you find that you are unable to edit the Routing Form, click the CHECK OUT button in the top left hand corner of the form and ensure the form is checked out to you. iv. Click the button once all of the questions have been answered, and then check the COMPLETE box located in the upper right corner of the browser window. The Routing Form window will close and return to the COMPONENTS FOR INITIAL APPLICATION screen. 4

5 STEP 3: COMPLETE THE INITIAL APPLICATION SUBMISSION COMPONENTS A. Edit the required Routing (eform) B. Download, edit, and upload the Application for Protocol Review C. Download, edit, and upload the Protocol (not needed for Exempt/Non-human Subjects Submissions) D. Determine which supporting documents are needed for the review submission E. Complete the Personnel Form (eform) F. PI Attestation Form G. Submit to COMIRB 5

6 B. THE APPLICATION FOR PROTOCOL REVIEW DOWNLOAD, EDIT, AND UPLOAD THE APPLICATION FOR PROTOCOL REVIEW: i. Download the Application for Protocol Review. *To save the Application for Protocol Review, or if it says Please Wait, press the download icon in your internet browser to download the Application Form to your desktop, then open the document from there using Adobe Reader (Always use an Adobe product to edit the Application for Protocol Review). Download Icons - Firefox: icon in the top right-hand corner; Chrome: icon in the bottom righthand corner; Internet Explorer: icon in the top-left hand corner. ii. Open the Application for Protocol Review (subsequently referred to as APPLICATION FORM) and answer the questions as they pertain to the research protocol. Be sure to SAVE the application form in a specified location, either on a shared drive or on a local hard drive. iii. To upload the Application Form into the era(infoed) system, click linked word UPLOAD. iv. On the screen that appears, click on the button next to the subheading labeled LOCATION, and then navigate to the folder or location where you have saved the completed Application Form and select the file. (At this point you should be prepared to upload your completed form to the era(infoed) Website.) Please ignore the other fields on the upload page besides Location. v. Click the UPLOAD button to add the document to the INITIAL APPLICATION screen. Once the browser window has refreshed and uploaded the Application Form, the UPLOAD link changes to REPLACE and the status changes to COMPLETED. vi. Click the REPLACE link if you find that you need to replace the uploaded document with another version. 6

7 STEP 3: COMPLETE THE INITIAL APPLICATION SUBMISSION COMPONENTS A. Edit the required Routing (eform) B. Download, edit, and upload the Application for Protocol Review C. Download, edit, and upload the Protocol (not needed for Exempt/Non-human Subjects Submissions) D. Determine which supporting documents are needed for the review submission E. Complete the Personnel Form (eform) F. PI Attestation Form G. Submit to COMIRB 7

8 C. THE PROTOCOL Download, edit, and upload the Protocol (not needed for Exempt/Non-human Subjects Submissions) i. Download the PROTOCOL TEMPLATE from the COMIRB Forms Library and save it to your computer: Protocol Template Save the Protocol to either your computer or a simple drive location for uploading (the longer the path name, the more likely you will encounter trouble uploading documents). Download how to complete the COMIRB s protocol templates Biomedical and Social if you need additional help completing the protocol template. ii. iii. Open the Protocol Template (subsequently referred to as the PROTOCOL) and answer the questions as they pertain to the research project. Be sure to SAVE the protocol form in a specified location, either on a shared drive or on a local hard drive. Click the ADD link located on the INITIAL APPLICATION screen. iv. NAME the document to be uploaded in the provided field in the format: Protocol-v-Version Date (i.e. Protocol-v ) v. Click on the button next to the subheading labeled LOCATION, and then navigate to the folder or location where you have saved the completed application form, and select the file. (At this point you should be prepared to 8

9 upload your completed PROTOCOL to the era/(infoed) system.) vi. Choose the appropriate category: PROTOCOL. Disregard the other provided fields marked out with red x s in the screenshot above. Then, click the UPLOAD BUTTON. vii. Click the CLOSE BUTTON to complete the upload of the PROTOCOL. STEP 3: COMPLETE THE INITIAL APPLICATION SUBMISSION COMPONENTS A. Edit the required Routing (eform) B. Download, edit, and upload the Application for Protocol Review C. Download, edit, and upload the Protocol (not needed for Exempt/Non-human Subjects Submissions) D. Determine which supporting documents are needed for the review submission E. Complete the Personnel Form (eform) F. PI Attestation Form G. Submit to COMIRB 9

10 D. SUPPORTING DOCUMENTS FOR PROTOCOL REVIEW i. Click the ADD link located on the INITIAL APPLICATION screen. ii. NAME the supporting document to be uploaded in the provided field. *Please name the document according to our naming convention. COMIRB electronically stamps documents in the top righthand corner which covers any content in that area. Please do not place content in the top right-hand corner of documents. The table below includes a list of supporting documents that may apply to a review submission: Consent forms, assent forms, verbal consent scripts; templates can be found here. HIPAA Authorization B (if not using combined consent and HIPAA); templates can be found here Grant application (only when funded by a federal grant) Surveys, diaries, questionnaires, interview guides, scripts used with subjects (if applicable) Other committee approvals (if applicable, including SARC, PRMC, RDRC, IBC, CIR) Investigator drug brochure or package inserts (if applicable) Recruitment materials, advertisements, invitations to participate, informational materials subjects (if applicable); click here for advertisement guidance. If you are submitting an advertisement, please use our Advertisement Components Submission Form that can be found by clicking here. VA or Denver Health clearance letter (if research is conducted at or involves employees of these sites) Documentation of IND number or exempt (if applicable) FDA 1572 Form (if applicable) Background information for food supplements (if applicable) Device manual (if applicable) Documentation of IDE number, Non-significant risk device determination or IDE exemption (if applicable) Conflict of Interest management plan (if applicable) HIPAA Authorization A (if applicable) for recruiting subjects; templates can be found here 10

11 iii. Click on the button next to the subheading labeled LOCATION, and then navigate to the folder or location where you have saved the supporting document and select the file. Please submit supporting documents as separate computer files and do not combine them as a single file. Please do not upload Microsoft Office Documents in read-only format and please do not submit Microsoft Outlook.MSG files. iv. Choose the CATEGORY that most appropriately coincides with the supporting document. Disregard the other provided fields marked out with red x s in the screenshot above. v. Click the UPLOAD BUTTON to add the document to the INITIAL APPLICATION. Once the browser window has refreshed, click the CLOSE BUTTON to complete the upload of the document. vi. Click the linked document name to confirm that the supporting document can be opened and is readable. Click the REMOVE if you find that you need to completely remove the document from the submission. vii. Please always upload a COVER LETTER that generally outlines your request for review, includes any information you feel is important for the reviewer to be aware of, and includes an itemized list of all the documents included in the submission. STEP 3: COMPLETE THE INITIAL APPLICATION SUBMISSION COMPONENTS A. Edit the required Routing (eform) B. Download, edit, and upload the Application for Protocol Review C. Download, edit, and upload the Protocol (not needed for Exempt/Non-human Subjects Submissions) D. Determine which supporting documents are needed for the review submission E. Complete the Personnel Form (eform) F. PI Attestation Form G. Submit to COMIRB 11

12 E. Personnel Form Last Updated: December 15, 14 All individuals involved with the study should be included on the PERSONNEL FORM. It is the investigator s responsibility to ensure that the list of individuals included on the PERSONNEL FORM is accurate. Our Application Form only includes room to list 3 individuals. These 3 individuals, along with everyone else involved in the study, should be listed on the PERSONNEL FORM (EFORM). i. Click the linked document name to edit the PERSONNEL FORM (EFORM). ii. Click the button to add all of the personnel involved with your study, and click the button to remove personnel. When you click the button, the listed individuals are organized alphabetically according to LAST NAME. To select someone to add to the study, first select the first letter of the individuals last name from the list of letters, and then begin typing their last name into the Search for a particular entry field. The individual s name should then appear in the dropdown menu. Be careful when selecting a name; there may be more than one person with same name in the system. You may have to click on DROP-DOWN MENU to view other names. There may be multiple listings for the same person. Please select the one with the relevant department after the name for the research being conducted. iii. If an investigator has never been a part of a COMIRB study click here for information on obtaining access to the era(infoed) system and completing new investigator tasks. iv. Select an appropriate ROLE from the dropdown menu for each individual. Then, please make sure that the individuals you add have current Certifications that they completed the two required (starred) instructional courses: the COMIRB HS (Human Subjects Protection) course and HIPAA Course. The HIPAA Course needs to be completed only once, so as long as it is listed, it is valid; however, the COMIRB HS Course needs to be updated every 3 years, so it is important to pay attention to the end date for this Certification. 12

13 v. Please click here for information on how to update or complete Certifications for the courses, if necessary. Also, Conflict of Interest Disclosures need to be completed once per academic year. The system is reset each year September 1 st at which time a new disclosure needs to be made. Instructions on how to refresh CITI Courses and submit a Conflict of Interest Disclosure can be found by clicking here. vi. Please ignore the START DATE and END DATE marked out with red X s above. vii. If you find that you are unable to edit the Personnel Form, click the CHECK OUT button in the top left hand corner of the form and ensure the form is checked out to you. viii. Click the button after everyone has been added, and then check COMPLETE box located in the upper right corner of the browser window. The PERSONNEL FORM will close and return to the COMPONENTS FOR INITIAL APPLICATION screen. 13

14 STEP 3: COMPLETE THE INITIAL APPLICATION SUBMISSION COMPONENTS A. Edit the required Routing (eform) B. Download, edit, and upload the Application for Protocol Review C. Download, edit, and upload the Protocol (not needed for Exempt/Non-human Subjects Submissions) D. Determine which supporting documents are needed for the review submission E. Complete the Personnel Form (eform) F. PI Attestation Form G. Submit to COMIRB 14

15 F. PI ATTESTATION FORM The PI Attestation Form gives the ability for the Principal Investigator to have another individual listed on the study submit on behalf of the PI. i. This requirement can be fulfilled in several different ways depending on whether or not the PI plans to submit themselves or plans to have another member of the study team submit on behalf of the PI. Click the linked name of the PI ATTESTATION form for instructions on the different options to meet this requirement. Once you have decided which option is appropriate for the PI, click the UPLOAD link to upload the appropriate document. ii. Select the file location then click the Upload button. --CONTINUE TO NEXT PAGE-- 15

16 STEP 3: COMPLETE THE INITIAL APPLICATION SUBMISSION COMPONENTS A. Edit the required Routing (eform) B. Download, edit, and upload the Application for Protocol Review C. Download, edit, and upload the Protocol (not needed for Exempt/Non-human Subjects Submissions) D. Determine which supporting documents are needed for the review submission E. Complete the Personnel Form (eform) F. PI Attestation Form G. Submit to COMIRB Your submission should look approximately like this before you Submit to COMIRB (depending on the supporting documents you upload); the STATUS for the Forms should be COMPLETED: 16

17 G. SUBMIT AND CONFIRM COMIRB HAS RECEIVED THE SUBMISSION When the NECESSARY documents have been uploaded into the submission, you can SUBMIT to COMIRB. Please note that this can only be done by the Principal Investigator for the study unless the appropriate form has been completed and uploaded for the PI Attestation Form. i. Click the button located in upper right corner of the INITIAL APPLICATION screen. If no button is present, please call COMIRB at ii. Select ACCEPTED on the CERTIFICATION window that appears. Click the CONTINUE button once you have finished. iii. Be aware that the next screen you see ROUTE PATH SCREEN only shows you the route your protocol is going to take. Your protocol has not yet been submitted until you click submit. Please do not click the link Add New Person to Review Path marked out with a red X below. If the submit it greyed out, please contact COMIRB at : 17

18 iv. To confirm that COMIRB has received your submission. Check the STATUS in the top right-hand corner of the screen. If the status says IN DEVELOPMENT then the submission was not completed and you should click the submit button again or contact COMIRB at The PI should receive a submission confirmation , regardless of who submits. v. When you have completed your submission, make sure to click the button in the top left hand corner of the screen to close the submission, otherwise, no one else will be able to edit the study later. vi. Mostly, COMIRB correspondence will be made through your UCDenver.edu account at If you have forgotten your password, please visit If you are not CU Denver faculty or staff, you were assigned an account when you applied for a POI Number. 18