Children s Research Management System (CRMS) Version 3.0. Children s Hospital Colorado Research Institute Training Guide April 2015

Transcription

1 Children s Research Management System (CRMS) Version 3.0 Children s Hospital Colorado Research Institute Training Guide April 2015

2 Table of Contents Operational Needs Assessment (ONA) 3 Visit Schedules 32 CRMS Login Home.3 CRMS Login Page...4 Setting up a Clinical Research Study..5 My Inbox Personal Page 6 CRMS - Personal Page...7 CRMS Search for Project 8 Project Workspace.9 Project Workspace Tabs..10 Activity Descriptions ONA General Information ONA Project Personnel.15 Project Conduct.16 Data and Materials Information.17 Material Transfer Agreement Funding Source..20 Final Step 52 Project Locations..21 Project Resources.22 Laboratory Service Information..23 Investigational Drug Services.24 Radiology Information 25 Research Informatics Support..26 CCRO and CTRC Resources.27 Clinical Research Coordinator Services..28 Radiation and Biosafety 29 Conflict of Interest..30 Study Design.31 Terms Used in this Document Arm Definition Cohort Definition.38 Interventions..39 Adding Interventions.40 Segment Definition.41 Adding Segment Definition Segment Order and Anchoring Procedure Definition..47 Adding Procedure Definition.48 Procedure-Visit Association Final Step Submit for ONA Review 53 CRMS States and Meaning.54 2

3 CRMS Login Home: 3

4 CRMS Login Page User Name: Children s Hospital PeopleSoft ID Number Password: Same password as you use to login to any desktop at CHCO 4

5 Setting up a Clinical Research Study The following diagram shows the essential steps for setting up a study in CRMS. Depending on the information you supply, other forms may be displayed to gather additional information. 5

6 My Inbox - Personal Page This page will appear when you login to CRMS. 1. Inbox This includes projects you are assigned to as part of the study team. The study workspace for these projects can be accessed. 2. Draft This includes your projects that have not been submitted for Operational Needs Assessment review and are in the Draft state. 3. Active Studies This includes all of your projects that are in the Active state. 4. All Studies This includes all projects in CRMS. Note: This includes all projects currently entered into CRMS. The project workspace can only be accessed for studies you are assigned to as part of the study team. 5. All Assigned Studies This includes all projects you are assigned to. Will include amendments as well as withdrawn studies. 6

7 CRMS - Personal Page Access this view by clicking on the CRMS tab at the top left. 1. Studies I have Access To This includes projects that you are assigned to as part of the study team. The project workspace can be accessed for these studies. 2. Draft This includes your projects that have not been submitted for Operational Needs Assessment review and are in the Draft state. 3. Active This includes all of your projects in the Active state which you are listed on as part of the study team. 4. Amendments This includes projects you are listed on as part of the study team going through the amendment process. 5. Search All Studies - This includes all projects in CRMS. You can only access the project workspace for studies you are listed as part of the study team on. 7

8 CRMS Search for Project 1. Filter by Options ID CRS Number (example CRS ) Name search by the project title, or a word in the project title using the % Date Modified search by the date the project was last modified Consenting search studies by whether or not there is a consent PI First Name search based on the principal investigator s first name PI Last Name search based on the principal investigator s last name Primary Sponsor search based on the primary sponsor of the project IRB Number search by COMIRB ID number G0 search by grant account number State search for studies in specific CRMS states Last State Change search by the date of the last CRMS state change 2. % as wildcard allows you to search by typing in only part of the text you want to filter by (Ex: %Gre finds 'Great', 'Green', and 'Greetings ) 8

9 Project Workspace 1. CRMS Project State see page 54 for CRMS state descriptions. 2. CRS Number & Project Title 3. Operational Needs Assessment (ONA) View/Edit Project Complete ONA form. Print Project creates summary of ONA information. View Differences shows changes made to original submission of the ONA. 4. Project Summary this summary includes important information about the project. 5. Next Steps Activities used for project specific actions (see pages For explanations of these activities) 9

10 Project Workspace Tabs 1. Summary Project Overview; including links to participant tracking, budget, and agreements workspaces 2. History Log of project activities and public comments 3. Clinical Information Ancillary specific project details 4. Financials Project budget overview (if funded) 5. Version History Shows amendments that have been created for the study 6. Upcoming Visits Project participants state 7. Supporting Documents - additional submission attachments pertaining to project 8. Regulatory Documents Approved IRB documents 10

11 Activity Description Log Event or Milestone is used during participant tracking to identify significant study milestones (generally for billing/invoicing purposes). After study team requests pre-award approval PI must execute this activity. Gives study team the ability to edit the ONA after the study has started the study-start up process. Study Team may request a grant account G0 to be setup and pre-award activated. This allows the study team to begin charging effort, supplies and equipment to the study. NOTE: This request does not allow study team to start to enroll subjects. Schedule a meeting for Initial Setup of studies which will document in EPIC. Note: An Epic Use plan is required for any study that will be consenting subjects (unless a waiver of documentation of consent is granted by IRB). IRB approval is required to schedule this activity This activity must be executed in order to begin the Research Institute study start-up process. Please be sure all information is complete in ONA before you execute activity Allows study team members to be added/or removed from project 11

12 Activities (continued) Description Upload any supplementary project agreements (DUA, MTA, etc). This is for any agreement that is not the project s primary agreement. Update the project Protocol if necessary Upload stamped/approved IRB documents Upload any additional documents pertaining to the project Remove the project from study start-up process Create a shell of the current project as a new project. Allows study team to edit the ONA information and submit a new project which is similar to the original one. Use with care. Add Comment to History tab in project workspace. Allows for tracking communication 12

13 ONA - General Information This is the first page you will encounter when you execute Create Study from your personal page 1. Enter the short project title: This should include: Sponsor name, short description or drug name, sponsor s protocol number or IRB number, and PI last name. 2. Enter the full project title: This title should be as it appears in the protocol. 3. Enter the PI name: Begin typing the name of the PI, a short list of names will appear. Click on the correct name to select. Alternatively, click Select and search for the PI. If you cannot find the PI s name select Other and list the PI in the provided space. Contact CRMS@childrenscolorado.org to get the PI added to CRMS. 4. Enter the project type: select the project type that best describes your project. If none of them apply select other and enter the type in the provided space. 13

14 ONA - General Information Continued 5. Project submission type: Select the sponsor type for the project. If there is no sponsor select unfunded. 6. Select the protocol type 7. Estimated start date for the project: Enter a realistic estimate of when you would like to start enrolling subjects in the project. 8. Indicate whether there will be an IND or IDE for the project. (IND: Investigational New Drug, IDE: Investigational Device Exemption 9. Attach the protocol for the project 10. Add any additional information about the project that you would like to add (Ex: Competitive enrollment with narrow enrollment period) Upon completion of all the information on this page click continue at the bottom of the page. 14

15 ONA Project Personnel 1. Department: will auto-populate based on the Principal Investigator s department 2. Section Head: will auto-populate based on the Principal Investigator s department 3. Business Manager: will auto-populate based on the Principal Investigator s department Note: if the information entered in any of the above fields is incorrect or missing please contact: CRMS@childrenscolorado.org 4. Research Coordinator: Select the Research Coordinator for the project. This person will act as the main study contact for the project. 5. Project Team: a popup window will open to select and add all study team members. Anyone listed here will have the ability to edit this study in CRMS. This list can be edited as needed by executing the Update Study Team activity from the project workspace. 15

16 Project Conduct 1. Select the emphasis area in which the project fits: Click Select and a popup will appear. Type in a discipline and click Find and choose from the list. Alternatively, you can just select Find without typing a discipline in to see the entire list of disciplines. 2. Are you obtaining consent? 3. Select the IRB of record for the project 4. Enter the IRB number: If you already have a COMIRB number please enter it. If you have submitted your project through the campus-wide Portal, this number should already be assigned to your project. 5. Enrollment Duration: select the amount of time the project will be open for subject enrollment. 16

17 Data and Materials Information 1. Data and Materials Information: Indicate whether data and/or materials will be leaving CHCO. Note: This includes sending data or materials to UCD These questions help our contract specialists determine if a data use agreement or a materials transfer agreement might be needed for your project. The earlier the team knows about the potential need for an agreement, the quicker your project will be ready to begin! 17

18 Material Transfer Agreement 1. Indicate whether CHCO is sending or receiving samples, and exactly where the samples will be sent or received from Add an address if possible 2. Describe what type of specimens will be sent or received Please be specific. Ex: Blood, Biopsy, etc. 3. Describe how the specimens will be labeled. This is a description of what will physically be on the samples. Ex: MRN, Date collected, Study ID, etc.

19 Material Transfer Agreement (Cont d) 4. Indicate the source of the specimens 5. Please explain exactly what analysis will be done on the specimens, or if the specimens will be banked 6. Indicate whether consent will be obtained for the specimens

20 Funding Source 1. Select the prime recipient on the Anschutz Medical Campus: Select the institution where the project s funding will be received first. (Ex: if UCD will receive funding, then a subcontract will be issued to CHCO, you would select UCD.) 2. Select the Primary sponsor for the project: Use the wildcard sign (%) as the first character, then begin typing the name of your sponsor. A list of potential matches will appear. Select the correct sponsor from the list. If your sponsor does not appear, select Other and indicate the sponsor in the area provided. 3. Additional Funding Source: Indicate any other funding sources for the project. Common additional funding sources are CTRC or a department. 4. Sponsor s primary contact information: Enter the sponsor s contact information by clicking Add. This information should include Name, Phone Number, and when possible. 5. Sponsor Protocol Number: Enter the sponsor s protocol number (if applicable) 6. Grant Number: Enter the grant number associated with this project (if applicable) 20

21 Project Locations 1. Select all locations where the project will be conducted. No need to enter all sites for a multi-site study, we are mainly interested in all local sites. 21

22 Project Resources 1. Clinical Laboratory: Select Yes if your project requires the Clinical Laboratory 2. Will you require a Custom Epic Build: Select Yes if your project requires a custom Epic Build Note: This is a service beyond normal Epic Setup and is used for reporting or other purposes besides documentation. 3. Investigational Drug Services: Select Yes if your project requires use of the research pharmacy 4. Radiology: Select Yes if your project requires the use of Radiology 5. Research Informatics: Select Yes if your project requires the use of the Research Informatics Core. 6. Short-term specimen storage: Select Yes if your project requires the use of the short-term specimen storage in the lower level of CHCO. 7. Shared Resources: Indicate any other ancillary services required for your project. 22

23 Laboratory Service Information 1. Will the laboratory process and/or ship samples as part of the study?: Select Yes or No 2. Upload laboratory manuals provided for the study here: click Add to upload any laboratory related documents (if provided) 23

24 Investigational Drug Services 1. Select all services being requested from the CHCO investigational pharmacy 24

25 Radiology Information 1. List protocol pages governing imaging: indicate which pages in the protocol detail the imaging being requested from radiology 2. Does the study sponsor request that technologists be trained on the imaging specifications stated in the protocol? Indicate Yes or No 3. Upload applicable imaging protocols: If provided separately from the main project protocol 25

26 Research Informatics Support 1. Select all support being requested from Research Informatics for your project. 26

27 CCRO And CTRC Resources 1. Will you require CCRO support services? Select Yes or No. If Yes, fill out the 4 questions below 2. CTRC Laboratory Services: If your project will require the CTRC Lab select Yes 3. Research Nursing Services: If your project requires nursing services outside of your department, select Yes. This includes the use of CTRC Nursing Services. 27

28 Clinical Research Coordinator Services 1. Select the services and resources needed for this project: Indicate all the services you are requesting from a CCRO clinical research coordinator. If not listed, select other and describe the service needed in the provided space. 28

29 Radiation and Biosafety 1. Biosafety: Indicate if your study has any biosafety concerns or mark if biosafety does not apply to your project. 2. Radiation Safety: Indicate if your study has any radiation safety concerns or mark if radiation safety does not apply to your project. 29

30 Conflict of Interest 1. Indicate if you have disclosed any potential Conflict of Interest to UCD 2. Indicate if this project overlaps with any relationships or responsibilities currently taking place 3. Indicate if UCD has informed you about a significant financial interest 30

31 Study Design 1. If Applicable, select the phase for your study, otherwise select N/A 31

32 Visit Schedules 32

33 Terms Used in This Document Term Anchoring Arm Definition Ties a study segment to a participant event, such as enrollment date or treatment start date for the purpose of projecting visit dates for the segment. A group or subgroup of participants in a clinical trial who receive specific interventions, or no intervention, according to the study protocol. This term is used to distinguish treatment groups primarily on interventional trials. Examples: Participant 1 was randomized to receive an investigational agent on Arm A. Participant 2 was randomized to receive the standard treatment on Arm B. A headache study evaluated a novel agent in Arm A compared to Ibuprofen and biofeedback therapy in Arm B, and compared to Ibuprofen alone in Arm C. 33

34 Terms Used in This Document Cohort Cycle Enrollment Intervention Open-Ended Cycle Procedure A group or subgroup of participants sharing some statistical factor (such as age, race, dosage level or risk level). This term is used to distinguish between participant groups on epidemiological and observational studies, as well as to further categorize participants receiving the same treatment on an interventional trial. Examples: For an observational study of the incidence of stroke in former smokers, participants were separated into cohorts based on length of smoking history (less than 10 years, years, and more than 21 years). Participants in a phase I study evaluating the safety of a new drug were divided into male and female cohorts. One course of a treatment that is repeated. A cycle is defined in terms of its timing, frequency and duration. A cycle can also be designated as open-ended. See Open-Ended Cycle. The process of engaging a person to be a participant in the study. This includes recording any required personal information, providing required disclosures to the participant, and obtaining documentary evidence of informed consent from the participant. A process or action under study that is performed on or by study participants. An intervention may involve a medication, a surgical procedure, the use of a device, an activity (for example, exercise or education), or refraining from an activity (for example, not smoking). A cycle that will repeat for an unknown duration for each participant, usually until the treatment or intervention is no longer working and the disease is progressing. An activity performed on or by participants for the purposes of the study. It is a more specific activity than an intervention, which may involve several procedures. The term Procedure includes and is often used interchangeably with the term clinical service. 34

35 Terms Used in This Document Screening A period after enrollment but before research begins during which subjects are evaluated for meeting study eligibility criteria and baseline data is collected. Typically, at least one distinct visit occurs during this period, referred to as a screening visit or a baseline visit. Segment Variance A stage of the study designated for a particular category of participant visits. For example, you might define segments for screening, treatment and follow-up visits. Also known as visit window. The tolerance within which a visit must occur to satisfy the study protocol. A visit outside the specified variance is considered a protocol deviation. For example, if a visit has a variance of 2 days, the participant may make the visit up to two days before or two days after the scheduled date and still satisfy the study protocol. Visit A scheduled participant appointment during which research defined by the study protocol is conducted. 35

36 Arm Definition This page allows you to set up all the arms for the study in one place. Arms are distinct visit schedules. Multiple arms should only be used if there are more than one distinctly different visit schedules. Most studies at CHCO only have one arm. 1. A row for one arm is set up by default. If there will be more arms associated with this study, click the Add drop-down-menu, select the number of additional arms you need, and then click the Add button. Perform the following steps for each arm. 2. The Name box supplies a default name for the arm. You can click in the box and replace this with a more descriptive name. 3. In the Description column, click in the text box and type a description of the arm. 36

37 Arm Definition 4. In the Type column, click the drop-down menu and select the arm type: o None o Experimental o Active Comparator o Placebo Comparator o Sham Comparator o Other 5. In the Duration column, click the drop-down menu for Unit Type and select whether the duration of the study is to be in days, weeks or months. In the Units box, select or type the number of days, weeks or months. 6. In the Enrollment column, enter the anticipated number of participants in that arm. The Status column shows what state the arm is in; the values are read-only. 7. To remove an arm, click the Remove button at the right of the row. 8. When you finish defining the arms for this study, click Continue. 37

38 Cohort Definition This page lets you set up all cohorts for the study. Keep in mind that cohorts are groupings of like participants but they share the same visit schedule structure. To set up a new cohort 1. Click the Add button. 2. On the resulting pop-up, type a name for the new cohort, and optionally, a description., then click OK. 3. To save this cohort definition and immediately define another, click the OK and Add Another button. If this is the last cohort you want to create at this time, just click the OK button. To modify an existing cohort 1. Click the Update button for the cohort you want to modify. 2. Make the necessary changes on the resulting pop-up, then click OK. To remove an existing cohort Click the Delete button to the right of the cohort you want to remove. 38

39 Interventions This page lists the arm(s)/distinct visit schedule(s) that have been defined for the study. For each arm, do the following: 1. Click the Add button. The Add Intervention pop-up appears. 39

40 Adding Interventions 2. In the Type box, select the name of the drug, procedure or other intervention. Drug Device Biological/Vaccine Procedure/Surgery Radiation Behavioral (e.g., Psychotherapy, Lifestyle, Counseling) Genetic (including gene transfer, stem cell and recombinant DNA) Dietary Supplement (e.g., vitamins, minerals) Other 3. In the Description box, type a descriptive term or phrase for the intervention if needed. 4. Click OK. 5. Repeat steps 1 4 for each intervention to be performed for that arm. 6. To remove an intervention, click the Delete button at the right of the intervention entry. 7. When you are satisfied with the interventions you have added, click Continue. 40

41 Segment Definition Studies are typically divided into one or more segments in which different categories of activity occur. For example, studies begin with a screening segment, which is typically followed by one or more treatment segments. Grouping visits into segments helps you organize and add procedures to your visit schedule. This page lets you add, modify and delete the segments for the study. NOTE: CRMS automatically adds a screening segment consisting of one visit to each study. You can add more visits to the screening segment, but you cannot remove the screening segment. 41

42 Adding Segment Definition 1. To define a new segment, click the Add button. The Create or Update Segments pop-up appears. 2. In the Name box, type the name you want to give this segment. 3. From the Segment Type drop-down menu, select Follow-up or Treatment. 42

43 Adding Segment Definition 4. Under item 3, select Yes or No to indicate whether or not the segment uses cycles. If you select No: a. From the drop-down menu under Segment Duration, select whether the duration of the segment is in terms of days, weeks or months. In the box to the left of the units, specify the number of units. *Tip you may want to have all segments as the full visit schedule length, which will allow your visits occur on days to sync with the master visit schedule. b. From the Visits Occur on drop-down menu, select whether visits occur on particular days, weeks or months. In the text box below the unit selection, type numbers indicating on which days, weeks or months visits occur. If you select Yes (indicating the study uses cycles), complete options a d. 43

44 Adding Segment Definition a. Select Yes or No to indicate whether or not cycles are open-ended. b. Enter a number designating the number of cycles in the study. If there is no set number of cycles, specify the number of cycles that you want to be used in calculating the budget. Typically this is an expected average per participant. c. Type numbers designating the days in each cycle that visits are to occur. You can designate a range of days with a dash between the first and last day. d. Type a number designating the number of days in each cycle. NOTE: Cycles must be specified in days. You cannot specify them in weeks or months. 5. Check boxes for the arms in which the specified segments are to occur. 6. When you are satisfied with your entries, click OK. 7. Click Continue. 44

45 Segment Order and Anchoring This page lists all segments currently used by the selected arm. It provides a way for you to specify when each segment begins. 45

46 Segment Order and Anchoring For each non-screening segment on the page, do the following: 1. In the Starts column, click the drop-down menu and select the event that you want to trigger the beginning of that segment. This is called anchoring the segment. *Tip if you have created all your segments to reflect the full length of the visit schedule, you can simply select Date of Consent for all segments. NOTE: Screening segments are anchored to the date of consent by default and you cannot change this. Further, you cannot anchor non-screening segments to the date of consent. 2. If you want to change the order of the segments, drag the handle at the left of a segment up or down to the new position that you want to assign it. 3. Click Continue. 46

47 Procedure Definition Use this page to define new procedures, and to modify and delete existing procedures. 1. To define a new procedure, click the Add button. The Create or Update Procedure pop-up shown below appears. 47

48 Adding Procedure Definition 2. Supply a description. 3. Select the sponsor paying for the procedure. 4. Check Optional Procedure If this procedure may not be needed for every participant. 5. Check Invoiced Separately if this procedure is to be a pass-through cost billed as a separate line item on visit invoices. 6. To save this procedure definition, click OK. To save it and immediately define another procedure, click OK and Add Another. 7. To modify an existing procedure, click its Update button and make the desired changes. 8. To remove an existing procedure, click its Delete button. 9. When you finish adding, modifying and deleting procedures, click Continue. 48

49 Procedure-Visit Association The primary purpose of this page is to enable you to specify during which visits of each arm particular procedures will occur. You can also: Specify the display name and allowed variance for specific visits by clicking the links in the column header. Change the order in which the procedures are listed by dragging the handles at the left of the rows up or down. 49

50 Procedure-Visit Association To modify the variance or description for a given visit, click the link representing that visit in the header row of the grid. To associate procedures with participant visits: 1. From the Arm Selector drop-down menu, select the arm for which you want to associate procedures with visits. 2. Click the name of a procedure that you want to associate with visits. The Procedure Visit Association page is displayed. 50

51 Procedure-Visit Association 4. Item 5 lists all the planned visits by study segment. For each segment, do the following: a. Check the boxes for visits during which this procedure will be performed. If a segment has been defined to use cycles, (as in Treatment 2 in the picture above), first select the cycles in which this procedure will be performed from the Cycle drop-down menu: All Even Odd Specify (Type the number of the desired cycle in the text box.) Then check boxes for the visits within the specified cycles during which this procedure will occur. b. For each visit in which this procedure will be performed, select the appropriate Billing Indicator from the drop-down menu: *Tip - RES is the system default RES (Research): The procedure is performed for purposes of the research study and/or is paid for by the study sponsor. SOC (Standard of Care): The procedure is a routine cost associated with a qualifying clinical trial and/or is billable to a third-party payer. NC (No Charge): The procedure has no charge associated with it and/or is not billable to the study sponsor or a third-party payer. 5. When satisfied with the settings on this page, click OK. The Procedure Visit Association page displays checked boxes for each visit with which you have associated a procedure. 6. When you are satisfied with the procedure-visit associations, click Continue. 51

52 STOP! If you will be preparing the budget, click here to access the Budget Training Guide. If you are submitting your Operational Needs Assessment (ONA) only please click Continue on the next 2 views (Budget Definition & Sponsor Agreement views) and then Finish. You will be routed back to the project workspace where you may execute the Submit for ONA Review activity. 52

53 Final Step Submit for ONA Review The project will remain in the Draft state until the Submit for ONA Review activity is executed. Note: Study Start-up for the project will not begin until this activity is executed 53

54 CRMS State & Meaning State Draft Meaning Further information is needed in order to submit the project for Operational Needs Assessment (ONA) review by executing the Submit for ONA Review activity. Routed for Review After the activity Submit for ONA Review is executed by a study team member, this status will appear. The project will be routed to the ONA Committee. Under ONA Review The project is now with the ONA Committee. Changes in Development Changes are being requested from the ONA Committee. Awaiting Final Documents This concludes the first phase of the project start-up. The system is now checking for approved budgets, agreements and IRB if applicable. Awaiting Institutional Setup Epic, PeopleSoft, Effort Certification and any other related systems are being set-up by Research Institute staff. Routed to Director of Child Health Research The study is in review by the Executive Director of Child Health Research. Approved, Pending Activation The Executive Director of Child Health Research has approved your project and all associated CHCO systems are now being activated for use. Pre-Approved Active On Hold Project has been pre-approved. However, until the project is fully approved, no data and/or samples are to leave Children s Hospital Colorado. A pre-approval letter will provide details. The project is now active at CHCO. Project is on hold until further notice. Complete The project is closed. 54