Research Participant Registration System (RPRS) Study Creation Guide

Transcription

1 Research Participant Registration System (RPRS) Study Creation Guide Revised August 2016 By Robin Richardson

2 Contents Introduction to RPRS... 3 Creating a Study Details Basic Details Stratification & Randomization Coordinating Center Funding Sponsor Principal Investigator Identifiers Consent Creating a Consent Creating a Consent Sub-Version Epochs & Arms Adding an Epoch to a Study Adding an Arm to an Epoch Eligibility Stratification Randomization Using Phone Call Randomization Using Book Randomization Randomizing Using the Upload Book Method Randomizing Using the Insert Book Method Companion Studies Overview/Summary Page(s) Overview Page Summary Pages

3 RPRS Study Creation Guide Introduction to RPRS The UAMS Research Participant Registration System (RPRS) is a web-based application used for end-to-end registration of patients to clinical studies. This process includes capturing the consent signed date, eligibility criteria, stratification, randomization, and screening results. RPRS can be run in a standalone mode where study definitions, investigators, personnel, and sites are entered into the system, or it can be run in an integrated mode with the AR- CRIS suite. RPRS also enables multi-site clinical studies where registration information is entered locally at affiliate sites, and the registration is completed by call-out to the coordinating site. This manual is designed to assist UAMS RPRS users, so some aspects of the software are skipped or summarized to provide adequate and accurate information specifically for our UAMS users. As a result, this guide may contain descriptions for components you do not have access to, or you may have superior functionalities not described in this guide. IMPORTANT: Do not open RPRS in more than one tab at a time you may lose data. Creating a Study Before you can begin registering subjects in RPRS, you must create, open, and activate the study site(s). To create a study in RPRS, click the Studies tab in the top navigation bar and select Create Study (Figure 1). Figure 1. Select Create Study from the Studies tab. 3

4 When Create Study is selected, you will see eight study information links, as well as an Overview link at the end. You must complete these eight information pages for a new study to be entered in RPRS (Figure 2). Figure 2. You must complete the first eight information pages to create a study. The following subsections explain the data that go into each information page. 1. Details At a minimum, fill in all required fields marked with a red asterisk (*). Following are explanations of each field Basic Details Fill out the following information under Basic Details (Figure 3): Figure 3. The required fields in the Basic Details section are indicated with a red asterisk (*). Study title: Enter the long title of the study or name of a protocol. Brief title (opt.): Enter up to 200 characters. Description (opt.): Enter a brief description of the study. Precis (opt.): Enter the structure summary description of the protocol document. 4

5 Target accrual: Enter the total number of subjects needed for enrollment within all sites according to the protocol. Threshold accrual (opt.): Enter the number of enrolled or off-study subjects for the study (value should be equal to or less than the target accrual) that will cause notifications to be sent to the EventTracker regulatory contact for the study. Therapeutic intent: Select Yes or No, based on whether there is treatment involved in the study. Phase: Select the phase from the drop-down menu. Blinded: Select Yes or No. This field is for informational purposes only and has no impact on RPRS functionality. Blinded by RPRS: Select Yes only if the study will use phone call randomization, in which case RPRS auto-randomization is required. Normally, this option is used when the study uses randomization kit numbers. You cannot change the RPRS Blinded selection once the Details page is saved and/or you move to another information page. If you selected Blinded by RPRS and want to change it, contact IT Research to remove the blinded and randomized options. If you select Yes for RPRS Blinded, the Randomized by RPRS field under the next subsection, Stratification & Randomization, will default to Yes and the Type will default to Phone Call randomization. For more information about phone call randomization, refer to section 7.1 Using Phone Call Randomization. Specimen Collecting (opt.): Select Yes or No. Version name/number: Latest version name (such as Original or Amended) or number of study. Note (opt.): Anything else that should be noted about the study s basic details. Membership Credit (opt.): Select from the drop-down list. Study types (opt.): Select all that apply. Use AERS (opt.): Check the box if the study will use the Adverse Event Reporting System. ICD code input required for registrations (opt.): Check the box if the individual creating or editing a registration must input a valid ICD10 code in the Enrollment Details section of the registration workflow. 5

6 1.2. Stratification & Randomization If No is selected for Blinded by RPRS in the Basic Details section, you will see the following options under Stratification & Randomization (Figure 4): Figure 4. If No is selected for Blinding by RPRS in the Basic Details section, Stratification & Randomization will have the options above. Stratified by RPRS: Select Yes or No. Selecting Yes will configure RPRS so that stratification can be defined within this study s epochs. Select No if you will stratify manually. Randomization by RPRS: Select Yes if you want the study to be randomized by RPRS, but only if the study staff want the registrations they enter to be automatically assigned by RPRS to an arm of the study. If you will use a custom randomization method outside of RPRS, such as non-book or non-phone, set this option to No, even if the study is randomized. If you select Yes for Randomization by RPRS, you will get the option to choose the Type of randomization you would like: Book or Phone Call. If you choose Book, be prepared to locate and upload the randomization book later in the process. For more information about Phone Call Randomization, please refer to 7.1 Using Phone Call Randomization. For more information about Book Randomization, please refer to 7.2 Using Book Randomization. If you selected Yes for Blinded by RPRS in the Basic Details section, you will see the following options under Stratification & Randomization (see Figure 5). Note that Randomized by RPRS will be automatically set to Yes, and Type will be set to Phone Call. Figure 5. The above is what the Stratification & Randomization options will look like if you choose Yes for Blinded by RPRS in the Basic Details section. Your only option in this section will be whether to choose Yes or No for Stratified by RPRS. A selection of Yes will configure RPRS so that stratification can be defined within this study s epochs. Select No if you will stratify manually. 6

7 1.3. Coordinating Center A typical user can only access the site to which he or she is assigned. Such users can only select one of their assigned organizations as the coordinating center (see Figure 6). Figure 6. Here you will enter required information about the organization or institution coordinating your study. Name: Begin typing the name of the organization or institution conducting the trial, and a list will appear for you to choose from. Study identifier: Enter the coordinating center identifier it may be a number, text, or a combination of both Funding Sponsor This section is optional, but if you have the information, enter it (see Figure 7). Figure 7. The Funding Sponsor section is optional, but if you have the information, enter the Name and Study identifier. Name: Begin typing the name of the organization or institution conducting the trial, and a list will appear for you to select from. If the funding sponsor s name does not appear in the list, contact UAMS IT Research for creation of the organization within RPRS. Study identifier: Enter the funding sponsor identifier it may be a number, text, or a combination of both Principal Investigator The information in this section is required (see Figure 8). Figure 8. The Principal Investigator information is required. 7

8 Organization: Begin typing the name of the organization of which the principle investigator is a member, and a list will appear for you to select from. If the Organization does not appear in the list, contact UAMS IT Research and ask them to create the organization within RPRS. Principal investigator: Begin typing the name of the principal investigator, and if he or she is in RPRS, a list will appear for you to select from. If the principal investigator does not show in the list, follow these steps: Step 1. Step 2. Click Create principal investigator in the Principal Investigator section of the Details page of the Create Study section. Fill out the required fields under Basic Details and Organization. To make creating a principal investigator easier, fill out the fields in the order indicated in Figure 9: Figure 9. This form is simpler to fill out if you follow the steps indicated above. Step 3. Click Save, then Close. You will be returned to the Details page. When all sections of the Details page have been completed, click Save & Continue. You will automatically be taken to the Identifiers page. If at this point you need to save and return to setting up your study later, you may close the program. 8

9 2. Identifiers The Identifiers information page is where you will enter IRB information, if applicable, by clicking Add Study IRB Identifier in the bottom left corner (Figure 10). Figure 10. If you have an IRB identifier, click Add Study IRB Identifier. Otherwise, click Save & Continue and move forward in your study creation. You will see the following screen (see Figure 11). Enter the IRB identifier in the red Identifier box, then click Save & Continue. Figure 11. Add the IRB identifier in the red box, then click Save & Continue. If you do not enter an IRB identifier, and RPRS determines that the study requires one, you will receive an asking you to enter the IRB identifier. 3. Consent On the Consent page in the Create Study section, you can add one or more consents to be signed for the current protocol. There may also be different versions of a consent. You will need to choose from the following options in the Mandatory consents drop-down menu (Figure 12): 9

10 Figure 12. At least one consent must be mandatory. At least one: Set Mandatory Indicator field to No for all consents. This setting indicates that when a subject is registered, he or she must sign one or more of the study s consents. All: Set the Mandatory Indicator field to Yes for each consent. None: Set the Mandatory Indicator field to No for each consent. As Marked Below: Consents may be arbitrarily marked as mandatory, but at least one consent must have the Mandatory Indicator field set to Yes Creating a Consent Follow these steps to add a consent: Step 1. Click Add Consent. The following subsection will display (Figure 13): 10

11 Figure 13. This section will appear after you click the Add Consent button. Step 2. Enter the following consent information: o Name: Enter the name of the consent. o Version/Code: Enter the version or code of the consent. o Mandatory Indicator: Indicate whether consent is required. o Sub-version Mandatory Indicator: If you select Yes, you must create at least one consent sub-version. (See the section below titled 3.2. Creating a Consent Sub-Version.) o Consenting Method(s): Select Written, Verbal, or both. Step 3. Once you have created all the consents you need, click Save & Continue. You will be taken directly to the Epochs & Arms information page Creating a Consent Sub-Version If you select Yes for Sub-version Mandatory Indicator, you must enter at least one Consent Sub-version. A consent sub-version allows you to have multiple versions of a single consent. When a subject is registered, you can select the most recent version of the consent using the original consent added to the study. So, when new consent versions are created for the study protocol, you do not need to create a new consent in RPRS; instead, you can add a new consent sub-version. 11

12 In RPRS, a consent can be signed multiple times, and different versions may be signed by the same subject. For example, a subject may have signed V7 of a consent form, then later sign V8 from the RPRS registration Overview page. You will see the following section when you select Yes for Sub-version Mandatory Indicator (Figure 14): Figure 14. If you choose Yes for Sub-version Mandatory Indicator, you must name the Consent Sub-version and indicate the Expiration Date. Follow these steps to add a Consent Sub-version(s): Step 1. Enter the Consent Sub-version name and an Expiration Date (opt.), then click Add Consent Sub-version. Another line for an additional Consent Sub-version will appear for you to add future additional Consent Sub-versions. The Expiration Date is optional upon creating a consent sub-version. It may be entered when a new sub-version is created and the previous one expires. Step 2. Once you click Add Consent Sub-version, a section will appear asking you to add a question(s) (Figure 15). Figure 15. If you add a Consent Sub-version, you will be prompted to add a question(s). At this point, you may add a question(s), add another consent, or click Save & Continue to move forward in creating your study. To add a question, do the following: 12

13 Step a. Enter a Question Code and Question Content. Step b. If you would like to add additional questions, click Add Question. Step 3. Step 4. You may continue to add consent sub-versions with or without questions. You may also select Add Consent to add an additional consent(s) with its own subversions and questions. Click Save & Continue. 4. Epochs & Arms The Epochs & Arms page allows you to create an enrolling epoch(s) for subject registration and add arms to the epoch(s) to describe the treatment approach Adding an Epoch to a Study Follow the steps below to create an epoch for your study: Step 1. Click Add Epoch from the main Epochs & Arms page (see Figure 16). Enter the following information: Figure 16. Enter the required information above to create an epoch for your study. o Name: Enter a coded value that indicates the general scope of activities that will occur in this epoch, such as Screening, Treatment, Follow-up, and so forth. 13

14 o Order: Select an integer value from the drop-down menu. If it is your first epoch, the only option will be 1. As you add epochs, RPRS will add order options. The Order value is used to define the order of this epoch relative to other epoch. Epochs with the same order value occur parallel in time. To capture screening failures, place a non-enrolling epoch with Screening type before the first enrolling epoch. o Type: Select from the drop-down menu. o Enrolling: Select Yes or No to indicate whether subjects are assigned to this epoch and are enrolled in the study. o Description (opt.): Enter a description of the epoch. o Accrual ceiling (opt.): Enter the maximum number of subjects allowed or expected to participate in the epoch. o Stratified by RPRS (only shows if Stratification by RPRS is set to set to Yes on the Details page): Select Yes or No. Step 2. Select either Add Arm, Add Epoch, or Save & Continue (see Figure 17). o To add another epoch, click Add Epoch and repeat the steps above. o If you select Add Arm, go to 4.2. Adding an Arm to an Epoch for instructions. An arm is not required for a treatment epoch if the study does not include randomization. A randomized study must include two or more arms for each treatment epoch. If only one arm is defined, the study cannot be activated and will remain in a Pending state. 14

15 Figure 17. Select either Add Arm, Add Epoch, or Save & Continue to move forward in creating your study Adding an Arm to an Epoch When you click Add Arm, the following will appear below the epoch information (Figure 18): Figure 18. When you click Add Arm in the Epoch section, you will see the above. To create an arm, do the following: Step 1. Step 2. Click Add Arm. Enter the following information: o Arm: Enter the name of the arm of the study. The default name is Arm A, but you may change it. o Description: Enter the details of the treatment arm or group. o Accrual ceiling: Enter the maximum number of subjects expected to participate in the arm of the epoch. You may create multiple arms by clicking Add Arm. Step 3. Once you are done adding arms, click Save & Continue to move on to Eligibility. 15

16 5. Eligibility The Eligibility page allows you to add inclusion and exclusion questions to determine subject eligibility. Here is what the Eligibility page will look like if you have entered multiple epochs (Figure 19): Figure 19. Above is how the Eligibility page will look when multiple epochs have been created, such as Screening and Treatment in this example. An eligibility checklist is a set of inclusion and exclusion questions that determine whether a patient is eligible to participate in the protocol. An RPRS user, such as a registered nurse, answers the checklist questions based on patient responses then registers the patient for the protocol if the subject is eligible for the study. All inclusion questions must be answered Yes, or RPRS will not allow the subject to move into the epoch without a waiver. Follow these steps to create eligibility criteria: Step 1. Select cadsr file to import. The cadsr is available at the NCI form builder website ( and contains the inclusion and exclusion criteria. To upload the cadsr, click Choose File, locate it, and press Open. If the study does not include any inclusion and/or exclusion questions, you can skip the next steps. Step 2. Add Inclusion Criteria to an epoch: 16

17 Step a. Click the plus sign (+) next to Inclusion Criteria in the appropriate epoch s section. Your screen will look something like this (Figure 20): Figure 20. You will add inclusion criteria questions in the Inclusion Criteria section. Step b. Step c. Step d. Step e. Step f. Click Add Inclusion Criterion. Enter a question serial number into the SN field. SN values should be integers in ascending order. Enter the complete text of a single Question or criterion on the eligibility checklist. The expected response is Yes. If N/A is a possible response to the question/criterion, check the N/A box. To add additional Inclusion Criteria questions, repeat Steps 3 5. To move forward to the next information page, Stratification, click Save & Continue. Step 3. Add Exclusion Criteria to an epoch: Step a. Click the plus sign (+) next to Exclusion Criteria. Your screen will look like Figure 21: 17

18 Figure 21. Create Exclusion Criteria questions following the same steps as in creating inclusion criteria questions. Step b. Step c. Step d. Step e. Click Add Exclusion Criterion for epoch. Enter the question s SN number. Enter the complete text of a single Question or criterion on the eligibility checklist of a protocol. The expected response is No. Click Add Exclusion Criterion to add additional questions, or click Save & Continue to go to the next information page, Stratification. 6. Stratification On the Stratification page, you can add questions, answers to the questions, and, based on the questions and answers, create stratum groups. When a subject is registering, he or she must answer the stratification question(s), and, depending on the answers, the subject will be placed in a certain stratum group according to the study's protocol. Stratification is only an option if Stratification on the Details and Epochs & Arms information pages are set to Yes. If you selected Yes to Stratification by RPRS for one or more epochs, these epochs will show on the Stratification page, such as in the Treatment epoch example below (Figure 22): 18

19 Figure 22. The Stratification page appears as above because the Stratification by RPRS option for the Treatment epoch was set to Yes. Follow these steps to Add Stratification Criteria: Step 1. Click Add Stratification Criterion. A place for a question and two answers will appear (Figure 23): Figure 23. You must enter at least two possible answers for each question. Step 2. Step 3. Enter a stratification Question and at least two possible answers. You may add more answers by clicking Add Answer. You may add more questions and answers by clicking Add Stratification Criterion. Once you have entered all of your questions, click Generate Stratum Groups to create stratum groups for the questions based on all the possible combinations of the answers to the set of questions. If you entered two questions with two possible answers each, you will see something similar to Figure 24: 19

20 Figure 24. RPRS creates groups with all the possible combinations of answers to the questions entered. The Group Number is the stratum group the subject will be assigned to based upon his or her answers to the questions. To change the order of the Group Numbers, click the triangles in the two left-hand columns to rearrange. If at any point you want to change the questions or answers after you ve generated the stratum groups, you may click Edit Stratification Criteria. Step 4. Click Save & Continue to move on to the next information page, Randomization. 7. Randomization In this section, you will enter details about randomizing your study if you selected Yes for Randomized by RPRS on the Details page of your study. If your study uses its own randomization method rather than lets RPRS randomize, always set Randomization to No on the Details page and skip the Randomization section. 20

21 If you selected Yes for Randomization by RPRS on the Details page for at least one epoch, the Randomization page will allow you to randomize your study subjects. The type of randomization can be either Phone Call or Book. With Phone Call randomization, you enter the phone number of your organization's designated randomization office in the Phone number field; when you register a subject to a randomized epoch/arm of the study, you call the office and find out what group to place the subject in. A Book is a list of entries that includes a combination of all the stratum groups and the subjects in a stratum group. From randomly-selected physicians, eligible, stratified subjects will be registered into the study. The Book option is available only when the study is stratified and stratum groups are assigned. The appearance and information entered on the Randomization information page will depend upon which method Phone Call or Book has been selected. The following sections explain how to fill out each option Using Phone Call Randomization If Phone Call randomization is selected, the Randomization page will look like the following example (Figure 25). In this example, the Treatment epoch is set to randomize by phone call. Figure 25. If Phone Call randomization is chosen for an epoch, the Randomization page will look similar to this one. Step 1. Step 2. For each randomized epoch, enter the designated randomization s office phone number in the Phone number field. Use one of the following formats: or Click Save & Continue to go to the next information page, Companion Studies Using Book Randomization A Book is a list of entries that includes a combination of all the stratum groups (if applicable) and the subjects in the groups. Each subject will be assigned randomly to a physician. 21

22 Here is how the Randomization page will appear when Book randomization is selected for the Treatment epoch (Figure 26): Figure 26. When Book randomization is selected, the initial Randomization screen will appear as above. Book randomization entry can be accomplished by either the Upload Book method using an existing document or by the Insert Book method using the RPRS data entry panel Randomizing Using the Upload Book Method If you already have a Book document, this is the method you will use. Step 1. With the Upload Book tab selected, click Choose File next to Select file to import. Locate the document and press Open. The uploaded file should be in.txt,.csv, or.doc format. RPRS does not support.docx file format. The data in the file must be in the following order: 1. Stratum group number (if applicable) 2. Position in the list of Book entries (must start with zero) 3. Name of the arm Step 2. Step 3. Step 4. Click Upload Randomization File. Review your entry from the Randomization Book panel. Click Save & Continue to go to the next information page, Companion Studies Randomizing Using the Insert Book Method If you do not already have a Book document, this is the method you will use: Step 1. Select the Insert Book tab. The page for the example Treatment epoch will appear as follows (Figure 27): 22

23 Figure 27. The above screen is what you will see when you select the Insert Book tab. Step 2. In the Randomization book text box, enter the following information in this format and order, separated by a comma, with each new entry on a separate line. See the example in Figure Position: Position describes the relative registration order. The position for each arm must begin with zero. 2. Arm Name: The name of the arm of the epoch. Figure 28. The above example shows the page after the randomization book has been entered and Upload Randomization Book has been clicked. 23

24 If there is stratification within the study, the information must be in the following order: 1. Stratification 2. Position 3. Arm Name Step 3. Step 4. Step 5. Once all Book information has been entered, click Upload Randomization Book. Review your entry from the Randomization Book panel. Click Save & Continue to go to the next information page, Companion Studies. 8. Companion Studies An explanation of functions for companion studies in RPRS is kept out of the scope of this guide because such studies are treated separately in UAMS. If you need companion study functionality in RPRS, please contact UAMS IT Research. 9. Overview/Summary Page(s) If you re creating your study all in one sitting and have at least filled out the Details page, you can go to Overview and see a synopsis of what you have set up so far. The Overview page (or Summary page, if you have edited your study) summarizes all of the information you entered about the study. The Overview and Summary pages have the same information, but the menu options are slightly different, depending on your role, whether you have previously edited the study, or whether the study is Pending or Open. (See section 9.2. Summary Pages to learn about the Summary page(s).) 9.1. Overview Page If you have not completed all of the necessary information for your study, your Overview page will look much like this (Figure 29): 24

25 Figure 29. If you have not filled out all necessary information to set up your study, you will initially see this dialog box. Click OK to view the overview of your study. Note a few things: On the Overview page, if the information is in red, it is not complete. Click the section name to open the page you want to edit. Make the changes/additions and click Save & Continue. Continue editing or click Overview to return to the Overview page. If the section name has a pencil icon ( ) next to it, you may click the section name to open the page for editing. (Alternately, you can click the section on the Create Study menu bar.) Make the changes/additions and click Save & Continue. Continue editing or click Overview to return to the Overview page Summary Pages Once you have closed the study whether you completed the setup or not when you reopen it, you will access it via Manage Study rather than Create Study. In the Manage Study section, you may see slightly different versions of the Summary page menu bar, depending on the status of your study, your role, and how you access the Summary page. 25