TrialSearch v2.0 User Guide

Transcription

1 TrialSearch v2.0 User Guide Revised August 2016 by Robin Richardson

2 Contents 1.0. Introduction to TrialSearch Searching or Browsing Studies Locating Trials and Viewing Trial Details Using the Search Option Locating Trials and Viewing Trial Details by Browsing Browsing by Cancer Browsing by Investigator Browsing by Service Line Reviewing Study Details Logging in to TrialSearch Editing Study Information Administering Protocol Editing External Contact Information Editing the Protocol Summary and/or Study Objectives and Outcomes Editing Eligibility Criteria Sending a Confirmation

3 1.0. Introduction to TrialSearch TrialSearch is a web portal designed in-house for UAMS that gives users access to all clinical trials at the university. It also serves as a place to indicate whether a trial will be made available to the public via uamshealth.com. You may view open trials in TrialSearch without logging in, but some functions require you to be logged in, as explained in 4.0. Logging in to TrialSearch. Editor s note: the terms trial and study are used interchangeably in this guide Searching or Browsing Studies You may access trial(s) information by either using the Search box or through the Browse trials by menu (Figure 1). Figure 1. You may Search for trials or Browse trials by Cancer, Investigator, or Service Line Locating Trials and Viewing Trial Details Using the Search Option Follow these steps to locate a trial and view its details using the Search box on the home page: 1. Click the Search box drop-down arrow and select the type of criteria you would like to use to locate the trial (see Figure 2). You may search by IRB #, Title, or Description. Figure 2. You may search by IRB #, Title, or Description. 2. Enter the keyword in the for text box. 3. Click Go. Trials that match your criteria will display (Figure 3). 3

4 Figure 3. The above trials were found using the Description keyword "breast." TrialSearch will only list trials that are published internally by protocol administrators. If you are protocol staff, and your study is not listed, log in to access the trial information. You will also see the study status, whether the trial has been published internally and/or externally, or whether it will not be published at all (Figure 4). Figure 4. The trial above is Open, but it has not been published internally or externally. 4

5 4. To view more details about the trial, click More about IRB #[XXXXX] (see Figure 5). See section 3.0 Reviewing Study Details for more information about the study details page. Figure 5. This page also has a link to C3PR and a Clinical Trials Referral Form, which will be discussed later in this guide Locating Trials and Viewing Trial Details by Browsing Follow these steps to browse for trials and view details about them: On the home page, click the desired browsing category (see Figure 6). You may browse by Cancer: Trials will be grouped by type and sub-types of cancer as determined in EventTracker. Investigator: Trials will be grouped by Principal Investigator. 5

6 Service Line: Trials will be grouped by Service Line as determined in EventTracker. Figure 6. Trials are grouped according to the category you select to browse by Browsing by Cancer Follow these steps to locate and view trials via browsing by Cancer: 1. Click Cancer in the Browse trials by menu. You will see something like Figure 7. 1 Figure 7. A list of cancer categories will display when you browse by Cancer. 2. Click the plus sign (+) next to the category of cancer you are interested in. A sub-list will display with a link to the studies (Figure 8). 1 Few trials are listed here because the training version of EventTracker was used when writing this guide. The active version will contain more studies. 6

7 Figure 8. "Other" is a link to trials on that type of cancer. 3. Click the sub-link ( Other in the examples above) to view the applicable trials. You will see a list of trials on that type of cancer (Figure 9). Figure 9. From the search results, you may export your search results to a CSV file, view the study status, and click the More about link to see the details (if you are logged in). TrialSearch will only list trials that are published internally by protocol administrators. If you are protocol staff, and your study is not listed, log in to access the trial information. 7

8 You will also see the study status, whether the trial has been published internally and/or externally, or whether it will not be published at all (see Figure 9). 4. To view details about a trial, click More about IRB #[XXXXX] (see Figure 9). Figure 5 is an example of a portion of a study details page. See section 3.0 Reviewing Study Details for more information about the study details page Browsing by Investigator Follow these steps to locate and view trials via browsing by Investigator: 1. Click Investigator in the Browse trials by menu. You will see something like Figure 10. Figure 10. Investigators are listed alphabetically with the number of studies they have been involved in. 2. Click the name of the investigator you are interested in. A list of the investigator s open studies will display (Figure 11). 8

9 Figure 11. This investigator has led one study. TrialSearch will only list trials that are published internally by protocol administrators. If you are protocol staff, and your study is not listed, log in to access the trial information. You will also see the study status, whether the trial has been published internally and/or externally, or whether it will not be published at all (see Figure 9). 3. To view details about a trial, click More about IRB #[XXXXX] (see Figure 9). Figure 5 is an example of a portion of a study details page. See section 3.0 Reviewing Study Details for more information about the study details page Browsing by Service Line Follow these steps to locate and view trials via browsing by Service Line: 1. Click Service Line in the Browse trials by menu. You will see something like Figure 12. Figure 12. The Service Lines are set in EventTracker. 2. Click the plus sign (+) next to the Service Line you are interested in, and you will see subcategories for you to choose from (Figure 13). 9

10 Figure 13. Each category of Service Lines has subcategories to choose from. 3. Some categories may be divided even further into more subcategories. Once you locate the subcategory you want, click the name of the subcategory to view the associated studies. TrialSearch will only list trials that are published internally by protocol administrators. If you are protocol staff, and your study is not listed, log in to access the trial information. You will also see the study status, whether the trial has been published internally and/or externally, or whether it will not be published at all (see Figure 9). 4. To view details about a trial, click More about IRB #[XXXXX] (see Figure 9). Figure 5 is an example of a portion of a trial details page. See section 3.0 Reviewing Study Details for more information about the trial details page Reviewing Study Details There are several ways to access trial details, as covered in the previous sections. Once you are on the details page, you can review many aspects of a study, such as (see Figure 14) IRB Number 10

11 Study Title Principal Investigator and Sub-investigator(s) (if applicable) information Contact Information (internal), which comes from other systems, such as CLARA Contact Information (external) Protocol Documents (with links) Protocol Training Documents and Other Non-required Documents (with links) Protocol Summary Study Objectives and Outcomes Eligibility Criteria (with multiple versions for different audiences) Diseases and Treatments Study Status You will also see a link to Create Registration in C3PR (Figure 9). If you click that link, TrialSearch will direct you to the C3PR Create Registration page. To learn more about C3PR, see the CRIS user guides. New tabs have been added under Eligiblity Criteria From Clara, Displayed Internally, Displayed Externally, For Patients, and For Physicians so that different versions of the criteria are available. Under Diseases and Treatments, you can Add more ICD10 codes in EventTracker by clicking the link. You will be taken to EventTracker where you may add codes for your study. For more information about EventTracker, see ICD 10 Code in the EventTracker User Guide. 11

12 Figure 14. You can learn much about a trial from the details page. 12

13 4.0. Logging in to TrialSearch You need to log in to TrialSearch to view unpublished studies and perform other administrative operations. Follow these steps to log in: 1. Click Login on the TrialSearch home page (Figure 15). Figure 15. You must log in to TrialSearch to access unpublished studies and perform administrative operations. 2. Enter your UAMS Username and Password, then click Sign In (see Figure 16). You will be returned to TrialSearch. Figure 16. Enter your UAMS Username and Password, then click Sign In Editing Study Information You must first log in to TrialSearch to edit a study protocol. See 4.0. Logging in to TrialSearch for more information. If you are protocol staff for the trial, or if you have administrative rights in TrialSearch, you may edit TrialSearch-related information, such as Administer protocol status (See 5.1. Administering Protocol Status.) Contact Information (external) (See 5.2. Editing External Contact Information.) Protocol Summary and Summary Objectives and Outcomes (See 5.3. Editing Protocol Summary and/or Study Objectives and Outcomes.) 13

14 Eligibility Criteria (See 5.4. Editing Eligibility Criteria.) Confirmation: Allows you to send a notification both to the protocol s principal investigator and to the protocol s contact personnel, letting them know changes have been made to the protocol. (See 5.5. Sending a Confirmation.) The following subsections explain editing the sections above Administering Protocol Once you have opened the trial details page (see 2.0. Searching or Browsing Studies) follow these steps to change study status or publish information on the trial. 1. Click Administer protocol (Figure 17). Figure 17. The Administer protocol button is below the Login/Logout link. 2. In the Administer this protocol section, click Yes or No (depending upon current status) for the applicable field to change the trial status (Figure 18). Figure 18. Some Administering options are not shown in the above image. You can mark whether o Trial is published internally: If set to Yes, any user within the UAMS network can access the study from within TrialSearch. 14

15 o Trial is published externally: If set to Yes, users may access study details from uamshealth.com. o Trial will never be published (not shown): If set to Yes, study details cannot be accessed from uamshealth.com or from within TrialSearch. You may no longer set enrollment status in TrialSearch; this property is configured in EventTracker Editing External Contact Information Once you have opened the trial details page (see 2.0. Searching or Browsing Studies) follow these steps to edit external Contact Information. 1. Click Administrator protocol (Figure 19). Figure 19. The Administer protocol button is below the Login/Logout link. 2. Click in the field under Contact Information (external) (Figure 20). Figure 20. Click the text under the heading box. 3. The edit field will open. Enter the new information into the field (Figure 21). 15

16 Figure 21. Enter changes in the Contact Information text box and click Save Changes. 4. Click Save Changes Editing the Protocol Summary and/or Study Objectives and Outcomes Once you have opened the trial details page (see 2.0. Searching or Browsing Studies) follow these steps to edit the Protocol Summary and/or Study Objectives and Outcomes. 1. Click Administrator protocol (Figure 22). Figure 22. The Administer protocol button is below the Login/Logout link. 2. Click in the field under Protocol Summary or Study Objectives and Outcomes to make changes (Figure 23). 16

17 Figure 23. Click the area under Protocol Summary or Study Objectives and Outcomes to open the text edit box. 3. The edit text box will open (Figure 24). Enter the new information into the text fields. Figure 24. Enter changes to the Protocol Summary or Study Objectives and Outcomes in the text field and click Save Changes. 4. Click Save Changes Editing Eligibility Criteria Once you have opened the trial details page (see 2.0. Searching or Browsing Studies) follow these steps to edit the Eligibility Criteria. 1. Click Administrator protocol (Figure 25). 17

18 Figure 25. The Administer protocol button is below the Login/Logout link. 2. In the Eligibility section, select the tab for the version you want to edit (Figure 26). Figure 26. Only administrators may make changes to the From CLARA eligibility criteria. 3. Click in the field under the selected tab and make needed additions/changes. 4. Click Save Changes Sending a Confirmation Once you have opened the trial details page (see 2.0. Searching or Browsing Studies) follow these steps to send an notification to the protocol principal investigator and to the protocol primary contact personnel about changes made. 1. Click confirmation (Figure 27). Figure 27. Send an confirmation to notify the PI and primary contact of changes made to the protocol. 18

19 2. The Send confirmation dialog box will open with the address(es) the notification will be sent to (Figure 28). Click Send . Figure 28. The addresses will already be displayed in the confirmation box, so you can just click Send . 19