era(infoed) Electronic Submission Instructions and Tips: Amendments, Changes, Updates

Transcription

1 era(infoed) Electronic Submission Instructions and Tips: Amendments, Changes, Updates This instructional document introduces users to submitting AMENDMENTS, CHANGES, AND UPDATES of ongoing research protocols electronically through the era(infoed) Portal. Any changes to an approved project require prior COMIRB review and approval, except when necessary to eliminate apparent immediate hazards to the subject. The requested change(s) must be described in sufficient detail for the reviewer to fully understand the changes, their impacts on the study procedures, and their impact on the study's risks and benefits. Before users submit documents electronically, they should first review the following required elements to gain era(infoed) access: The COMIRB Database is accessed through the era(infoed) Portal. If you are an Employee of the University of Colorado Denver, you have the ability to log into this portal using your CU Denver employee login information. If, however, you are a Researcher or Staff Member at a UCD Affiliate Site, user access to the era(infoed) portal 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. 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: LOCATE AN EXISTING PROTOCOL A. Select the MY HUMAN SUBJECTS TAB from the menu located on the left-hand side of your browser window. B. Click the SEARCH FOR and enter the protocol number in the field labeled PROTOCOL NUMBER. 1

2 C. Press Enter/Return. The results will appear at the bottom of the window. Select the icon to open the study in a new window. D. Click on the Submissions tab in the navigation bar. E. Select AMENDMENT from the drop-down menu located on the upper right-hand side of your browser window. Click the ADD BUTTON refreshing the window to the AMENDMENT screen. 2

3 The AMENDMENT screen looks like this: HELPFUL TIPS CO-INVESTIGATORS AND RESEARCH PERSONNEL who are not listed on the protocol will not see the protocol listed in their search results; they must be added to the protocol before having viewing permissions. Step 3: Complete the Amendment Submission Components The COMPONENTS FOR THE AMENDMENT 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 the level and type of review. (Here are ways to edit, download, attach, and upload documents required for protocol review.) A. Complete the Change Form. B. Upload Revised Documents. C. Complete the Personnel Form D. 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: 3

4 A. Completing the Change Form Download, edit, and upload the Change Form i. Download CHANGE FORM by clicking here. Save the CHANGE FORM to your computer, then complete the form. *To save the Change Form, or if it says Please Wait, press the download icon in your internet browser to download the form to your desktop, then open the document from there using Adobe Reader (Always use an Adobe product to edit the Change Form). 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. On the AMENDMENT screen and click the UPLOAD link. iii. Click on the button next to the subheading labeled LOCATION, and navigate to the folder, or location where you have saved the completed CRV form, and select it. (At this point you should be prepared to upload your completed form to the era(infoed) Portal.) Please ignore the other fields on the upload page besides Location. 4

5 iv. Once the document has been uploaded, click the linked document name CR FORM to view the uploaded form. Click the REPLACE link if you find that you need to replace the document you uploaded. Step 3: Complete the Amendment Submission Components A. Complete the Change Form. B. Upload Revised Documents. C. Complete the Personnel Form (Only required if Amendment includes changes to Personnel) D. Submit to COMIRB 5

6 B. UPLOADING REVISED DOCUMENTS COMIRB requests that you revise and submit study documents to reflect requested changes to the study. Often, information relevant to your requested change could appear on multiple documents. For instance, if you needed to make changes to a survey for your study, that may involve revising sections of your Application for Protocol Review Form, your narrative protocol, and the survey itself because all of those documents could include information relevant to changes in your survey. COMIRB electronically stamps documents in the top right-hand corner which covers any content in that area. Please do not place content in the top right-hand corner of documents. To submit an Amendment, it is necessary to upload 2 copies of the revised version of each document you are amending. One copy of the revised document should have the sections you revised highlighted in Pink or Blue, or have the changes tracked using Microsoft Word. The other copy of the revised document should not be highlighted. The highlighted copy is so our reviewers can easily determine what in the document has been revised, and the un-highlighted copy will be stamped approved as the official copy of that document. If you are submitting a document to COMIRB for the first time that is not a revision of a previously submitted document (e.g. you are adding a completely new survey to your study), you do not need to submit a highlighted copy. We STRONGLY SUGGEST that you highlight documents on your computer using the appropriate program, rather than highlight the revised documents by hand. Depending on the file type, Microsoft Word (for Word documents) and Adobe Acrobat Reader (for PDF documents) have the capability to highlight sections of text. You can also use Microsoft Word s tracked change feature to highlight documents. Important Note: If, and only if, you are making changes to the Smart PDF version of the Application Form, the version found here: instead of uploading a highlighted copy of the revised Application Form, please upload a copy of the un-revised version of the Application Form. In addition, you should also upload an un-highlighted copy of the revised Application Form. Please note that this is only the case for changes to the Smart PDF version of the Application Form: all other documents submitted for with the Amendment should include an un-highlighted copy of the revised document and a highlighted copy of the revised document. This is because we have special software that can compare the unrevised version of the Smart PDF version of the Application Form, to the revised version of that form. It is not possible to highlight or track changes on the Smart PDF version of the Application Form without special software. ii. Click the hyperlink ADD link located on the AMENDMENT SCREEN. 6

7 iii. *If your study uses the electronic version of the Application Form generated by the era(infoed) system please click here for instructions on how to add this Application Form to your submission. If not, move on to the next step. iv. Name the supporting document to be uploaded in the provided field. *Please name the document according to our naming convention. iv. Click on the button next to the subheading labeled LOCATION, and 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; however, if you are using a version of the Application for Protocol Review form for which the Application and Attachments (A-T) are separate Microsoft Word files, please combine the Application and Attachments together as one PDF file, if possible. To do this, you will need the program Adobe Acrobat Pro. v. Choose the CATEGORY that most appropriately coincides with the supporting document. Please ignore the other sections marked out with red x s in the screenshot above. vi. Click the UPLOAD button to add the document to the AMENDMENT SCREEN. Once the browser window has refreshed, click the CLOSE button to complete the upload. Select the linked name of each document to confirm that the supporting documents can be opened and are readable. Click the REMOVE link if you find that you need to completely remove the document. 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. 7

8 Step 3: Complete the Amendment Submission Components A. Complete the Change Form. B. Upload Revised Documents. C. Complete the Personnel Form (Only required if Amendment includes changes to Personnel) D. Submit to COMIRB Last Updated: December 15, 14 8

9 C. Personnel Form (eform) If you do not plan to make any personnel changes as part of this Amendment, skip to Step vii below. If you do plan to make changes to the personnel involved with your study, all individuals involved with the study should be included on the new interactive PERSONNEL FORM (EFORM) available through the era(infoed) system. The individuals listed on the Personnel Form should be identical to the individuals listed in the Application Form. So, if you make changes to the individuals listed on the Personnel Form, you need to also make those changes to the list of personnel included on the Application Form for your study. If you are using the new Smart PDF Application Form that only has space to list 3 key people who COMIRB may need to contact in case of a problem, those 3 individuals, along with everyone else included in the study, should be listed on the Personnel Form. We require only 3 people to be listed on the Smart PDF Application Form itself so that most personnel changes will require the investigator to only edit the PERSONNEL FORM (EFORM). The Smart PDF Application Form itself will only need to be revised if changes to those 3 key people are made. Important Note: Please list any changes you are making to personnel on the CHANGE FORM, along with adding and removing individuals from 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. Enter an END DATE to remove them from the study. Please remember to also list any personnel changes on the CHANGE FORM. IMPORTANT NOTE: Any individuals who have an End Date filled in are not currently active on your protocol and have been previously removed. iii. The listed individuals are organized alphabetically according to LAST NAME. Please note: be careful when selecting a name when there is more than one person with same name in the system, you may have to click on DROP-DOWN MENU to view other names. If the individual does not have access to the era(infoed) system they will not be available to add. If an investigator has never been a part of a COMIRB study click here for information on obtaining access to the COMIRB era(infoed) data system and completing new investigator tasks. 9

10 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 Human Subjects Protection (COMIRB HS) 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. 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. 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 window will close and return to the COMPONENTS FOR AMENDMENT screen. 10

11 Step 3: Complete the Amendment Submission Components A. Complete the Change Form. B. Upload Revised Documents. C. Complete the Personnel Form D. 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: 11

12 D. Submit and Confirm COMIRB Has Received the Submission- Amendments can be submitted by any member of the research personnel. When the NECESSARY documents have been uploaded into the submission, you can SUBMIT to COMIRB i. Click the button located in upper right corner of the AMENDMENT screen. If no button is present, please call COMIRB at ii. Select ACCEPTED on the CERTIFICATION window that appears. You may receive this screen. 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 : 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 12

13 submit button again or contact COMIRB at The PI should receive a submission confirmation e- mail, 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. 13