CRIS User’s Guide – Research Team Member Procedures for Managing CRIS Study Records, Adding Patients, Updating Statuses, For Use by KUMC Clinical Research Teams
Table of Contents Getting Started .......................................................................................................................................... 1 Wording Conventions ........................................................................................................................... 2 Log‐in to CRIS ........................................................................................................................................ 2 User Rights and Access ......................................................................................................................... 2 CRIS Homepage ......................................................................................................................................... 3 Searching for a Study ............................................................................................................................ 3 Advanced Search ................................................................................................................................... 3 Creating a New Study Record ................................................................................................................... 4 Determining Responsibility ................................................................................................................... 4 Creating the Record .............................................................................................................................. 4 Explanation of Study Status ...................................................................................................................... 8 Publish to Hospital Billing ..................................................................................................................... 9 Add a New Patient to CRIS, Associate Patient to a Study ......................................................................... 9 Searching and Editing Patient Information ......................................................................................... 11 Change a Patient Status .......................................................................................................................... 11 Marking Visits Complete ......................................................................................................................... 13 Editing Study Events ............................................................................................................................ 13
Getting Started CRIS is designed to help manage many parts of a clinical research project. CRIS has the capability to track and store subject enrollment data, regulatory information, study related documents, study calendars, and budget information. CRIS offers a single system to securely store and retrieve information on all subjects from past and current research projects. It also plays a critical role in study billing compliance. Investigators conducting interventional, observational, ancillary or correlative research studies at KUMC must register the studies in CRIS. . ANY study that utilizes KU Hospital services, including laboratory and pharmacy, OR is an interventional study running through the RI must enter subject data into the system. CRIS is recommended for all departments, divisions and study teams that are currently active in clinical research or just starting out with a single study.
CRIS V11 Research Institute Clinical Research Administration
This user’s guide covers:
The CRIS interface and functionality Required fields to be maintained and updated for a study Required subject demographic data (importance of using MRN as the Patient ID) Explanation of subject statuses
This guide lays out the data entry requirements for CRIS. All required fields should be updated within 48 hours of any status change (study / subject). If you have any questions or concerns about CRIS, please contact CRIS (
[email protected]) or your Clinical Research Administration (CRA) contact. Following this guidance will standardize data entry into CRIS across KUMC. A copy of the current KUMC policy on CRIS can be found in the policy section of Research Institute website. The link is titled “Protocol Management.” The policy is titled “Protocol Management and Research Participant Data Entry in CRIS.” The current policy is located at: http://www.kumc.edu/Documents/ri/spa/Protocol_Management3.1.04.pdf Wording Conventions Words in Red indicate an internet window or page name. When brackets [ ] are around a word, it signifies a link or icon to click. Bolded Words signify menu options to click. Log‐in to CRIS Access the CRIS system via cris.kumc.edu. Use your myKUMC username and password to logon. You must have pop‐up blockers disabled in order to open CRIS. CRIS opens in a new window to comply with HIPAA regulations. Access to the CRIS system is available ONLY after completing training. If you have not completed CRIS training, you will not be able to logon. Complete the CRIS Training Request Form (https://redcap.kumc.edu/surveys/?s=9WTnyI) to sign up for a one‐on‐one or group training session. The recommended browser is Firefox. If you do not have Firefox, it is free to download. You can download it at: http://www.mozilla.org/en‐US/firefox/new/ User Rights and Access The CRIS system has many types of user access. From a data security perspective, users will only have access to the data they are approved to see and/or edit. Data are saved in the Study Administration and Patient Management modules for each record. Study Administration is used to capture study information, document storage, and regulatory data. Patient Management is used to input and store study subject data.
CRIS V11 Page 2 of 14
User rights are defined by a person’s role on the study or by their position at KUMC. The most common roles used in CRIS are: 1. Principal Investigator 2. Study Co‐Investigator 3. Study Coordinator 4. Regulatory Administration 5. Clinical Data Manager 6. Monitor Access rights are pre‐defined based on your role. You must contact CRIS if you need to change your access rights. Changing your access rights may require approval from the RI, Cancer Center (KUCC) or your Department.
CRIS Homepage After logging in to CRIS, you are directed to the Homepage. From this page you can reach most areas of the system. Searching for a Study The easiest and quickest way to search for a study is via the Homepage. The search function on the Homepage searches the Study Number, protocol title and keyword fields. A study number is the IRB# or CRA#, most of the time (if neither, see Study Definition section). If a study has not yet been assigned an IRB #, it is entered according to CRA naming conventions (CRA_[Sponsor]_[Protocol ID]). To find a study, enter the IRB# or CRA# into the Search bar. If you are unable to find the trial by IRB#, title or keyword, click the [Advanced Search] link to search according to other criteria, for example, principal investigator. If you still cannot locate the study, email your contact in the CRA for assistance. Advanced Search The Advanced Search page allows you to search a study by many different criteria. The advanced search function is a great tool to use if you need information on more than one study. Fields to search by include: Study#, Title or Keyword, PI Name (First and/or Last), Study Team Members, Therapeutic area, Division, Agent/Device Name, Study Phase, Current Status. After searching by the criteria you choose, the list of studies meeting that criteria will be displayed on the same page. Click on the icon to display the Study administration module for an individual study. Click on the icon to display the Patient Management module. You can also click on the icon to export the list of studies to excel.
CRIS V11 Page 3 of 14
Creating a New Study Record Determining Responsibility A study must only be entered into the system one time. Multiple records for the same study will adversely impact reports and lead to confusion over which is the “correct” record. All records entered into the system are to follow guidance detailed in this section. Before entering a new study into CRIS, ensure that you are the appropriate person to do so and that it has not already been entered. If there is any question about whether or not it has already been added to CRIS, contact the CRA or Cancer Center Regulatory Office (CCRO). If the administrative and regulatory activities of your study are being handled by the CRA or CCRO then they will create the study record in CRIS. If a study meets requirements to be in the system, but it is not running through the CRA or CCRO, it is the responsibility of the Investigator or their designee to contact the CRA or CCRO to create the study. Note: When the CRA or CCRO creates the record in the system for an investigator, a copy of the protocol, consent form and IRB initial approval letter need to be provided. Creating the Record 1. Click Manage on the Menu Bar in the top left corner of the screen. 2. A second menu will appear after this. Under Studies menu, click [New]. This directs you to the Summary tab. The Summary tab contains fields that will be used to identify and classify your study. 3. Fields on the Summary page are to be completed as follows: (* = required field) a. Study information section: i. *Study Entered By: This is defaulted to the person creating the record. ii. *Principal Investigator: Lead PI on the Study. Click [Select User] to the right of the text box. This opens the User Search window. 1. To search for a user, change “Organization Name” to “Select an option” 2. Enter the First or Last name of the PI in appropriate field. 3. When found, click on either the first or last name of the person in the search results section of the window. iii. If Other: If there is a Co‐Principal Investigator on the study, type that name here iv. *Study Contact: Main contact for the study. Often times a Study Coordinator. This is the person who will be chiefly responsible for subject recruitment/enrollment. Study related bills will be forwarded to this person. Follow steps 1‐3 in part ii. above to add the user. v. Checkboxes: Check to indicate TRUE, when applicable. 1. Principal Investigator was a major author/initiator or this study? 2. CTRP Reportable (for Cancer and Cancer‐related studies‐excluding chart review and registry studies)
CRIS V11 Page 4 of 14
3. FDA Regulated Study (does the study involve an FDA regulated intervention?) 4. IND/IDE Information Available? If checked, answer the following: a. *IND/IDE Types b. *IND/IDE Number c. *IND/IDE Grantor d. *IND/IDE Holder Type e. NIH Institution, NCI Division/Program Code f. Expanded Access g. Expanded Access Type h. Exempt b. Study Definition section: i. *Study Number: Use the IRB# (i.e. STUDY12345678). If the IRB# is not yet available, enter temporary ID. If temporary ID is used, this field must be updated to the IRB# when it becomes available. Examples of temporary IDs include: 1. CRA – CRA_Sponsor_Protocol ID (for studies running through the CRA) For studies not running through CRA, temp ID examples include: 2. Grant – Department_Grantee_Protocol# 3. Industry – Department_Sponsor_Protocol# 4. Investigator‐Initiated – Department_IIT_Protocol# ii. *Title: Enter as it appears on the Protocol. iii. Objective: Outcomes for research project, usually the primary objective as defined by the protocol. If the study is registered on clinicaltrials.gov, objective will be pulled from the Purpose listed in the registration. iv. Summary: Lay explanation of the study. If the study is registered on clinicaltrials.gov, language will be pulled from the Detailed Description, and potentially Eligibility Criteria, fields listed in the registration. v. NCI Trial Identifier: This field is only displayed for those trials that were marked as CTRP reportable in the Study Information section. Number will be entered after CTRP registration by the CCRO. vi. NCT Number: Number assigned by clinicaltrials.gov. If the study is not registered on the site when it’s received, this field will be left blank until the number is available. If the study will not be registered on clinicaltrials.gov, NCT00000000 is entered. c. Study Details section: i. Agent/Device: Drug(s) or Device being studied. If more than one intervention/drug, separate using the word and (e.g. Cisplatin and radiation). ”N/A” is entered if the study does not involve a drug or device. ii. Division: Choose most appropriate division based on Principal Investigator. iii. *Therapeutic area: Select the most appropriate option for the study.
CRIS V11 Page 5 of 14
iv. *Disease site: Click [Select Disease Site(s)] to the right of the text box. This opens the Disease Site Lookup window. 1. Check next to the most applicable Disease Site. For non‐cancer studies, choose from options starting with “NC”. If there is not a fitting disease site option, select “Non‐cancer”. 2. Click “Submit” at the top or bottom of the window. v. National Sample Size: planned enrollment for entire study 1. KUMC Projected Enrollment: Click [Local Sample Size] next to the National Sample Size field. This opens the Local Sample size window. Projected local enrollment entered under KUMC, unless study is taking place in Wichita. vi. Study Duration: Anticipated length of time it will take a subject to complete their participation. vii. Estimated Begin Date: Estimated date of first enrollment. d. Study Design section: i. *Phase 1. Pilot/Feasibility: a. Pilot study: a version of the main study that is run in miniature to test whether the components of the main study can all work together. It is focused on the processes of the main study. b. Feasibility study: Pieces of research done before a main study. They are used to estimate important parameters that are needed to design the main study. 2. Phase 0: Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (i.e. screening and microdose studies). 3. Phase I: Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and or patients. 4. Phase I/II: Trials that are a combination of phases 1 and 2. 5. Phase II: Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short‐term side effects and risks. 6. Phase II/III: Trials that are a combination of phases 2 and 3. 7. Phase III: Includes expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit‐risk relationship of the drug and provide an adequate basis for physician labeling.
CRIS V11 Page 6 of 14
8. Phase IV: Studies of FDA‐approved drugs to provide additional information including the drug’s risks, benefits and optimal use. 9. Device: Studies involving devices as the investigational agent. 10. N/A: For trials that do not involve drug or biologic products This will possibly include epidemiologic, cancer control/behavioral, observational, ancillary, correlative or other biological studies, and expanded access (i.e. chart reviews, registry). ii. *Research Type: 1. National/cooperative group/consortium: NCI and NIH network supported studies. This includes all cooperative group, network and consortium studies. 2. Institutional/Investigator‐Initiated: In‐house clinical research studies authored or co‐authored by KUMC investigators. The KUMC investigator has primary responsibility for initiating and conducting the trial. a. Industry and other entities may provide support (i.e. drug, device, monies, other support). b. This category may also include: i. Institutional studies authored and implemented by investigators at another Center (i.e. CTSA Partner Institution). ii. Multi‐site institutional studies authored and implemented by investigators at KUMC. 3. Externally Peer‐Reviewed/Federal Funding: R01s, SPORES, U01s, U10s, P01s CTEP, or any other clinical study mechanism supported by the NIH or an approved peer‐reviewed funding organization. 4. Industrial/Pharmaceutical: The design and implementation of these clinical research studies is controlled by pharmaceutical company. iii. Study Scope iv. *Study Type 1. Diagnostic: Protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition. 2. Health Services Research: Protocol designed to evaluate the delivery, processes, management, organization, or financing of health care. 3. Prevention: Protocol designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition. 4. Screening: Protocol designed to assess or examine methods of identifying a condition (or risk factor for a condition) in people who are not yet known to have the condition (or risk factor). 5. Supportive Care: Protocol designed to evaluate one or more interventions where the primary intent is to maximize comfort,
CRIS V11 Page 7 of 14
minimize side effects, or mitigate a decline in the participant’s health or function. In general, intervention not intended to cure a disease. 6. Basic Science: Protocol designed to examine the basic mechanisms of actions (i.e. physiology, biomechanics) of an intervention. 7. Treatment: Protocol designed to evaluate one or more interventions for treating a disease, syndrome, or condition. 8. Other: Not in any of the other categories. v. Study Linked To: If trial is an ancillary protocol, select the main protocol. vi. Blinding: Select most appropriate option. vii. Randomization: Select most appropriate option. e. Sponsor Information section: i. Sponsor Name: Choose from drop down list. If Sponsor/Funding Source is not on the list, email
[email protected] and request its addition. If the study is an Investigator Initiated trial and unfunded, choose “None”. ii. If federally funded, check “NIH Grant Information” checkbox. You must answer: 1. *Funding Mechanism 2. *Institute Code 3. *Serial Number 4. *NCI Division/Program Code f. Keywords: Enter any phrases that will assist people who may search for this study. Separate keywords with a comma. Include any study identifiers like the sponsor’s protocol number, indication, or protocol acronyms. 4. When all required fields are complete on the Summary page, enter your e‐signature and click the Submit button.
Explanation of Study Status The study status is used to track the enrollment status of the protocol. The information is found by clicking on the Study Status tab. Every study in CRIS will have a status associated with it. For studies managed by the CRA, below is a list of statuses used. No study status is deleted. This is to track the progression of the study in the system. Only one status is marked as the CURRENT status. The CURRENT status reflects the enrollment status of the study. It is critical the study is marked correctly. For studies marked to publish to hospital billing, study and subject data is included in the daily transfer of data, between CRIS and O2, for all studies that are enrolling or in follow‐up. If a status is not accurate for a study, notify your CRA contact immediately. 1. Trial Status – Not Active (default status): Date the trial is entered into CRIS. 2. Trial Status – (2) Active/Enrolling: Date the trial is ready to start accruing patients. It is “good to go” with IRB approval, all contracts in place, drug available, SIV has occurred, etc.
CRIS V11 Page 8 of 14
3. Trial Status – (3) Follow‐Up/Closed to Enrollment ‐ Date the trial is permanently closed to new registrations. This may occur for several reasons. Examples: date of sponsor notification or target accrual met. 4. Trial Status – Terminated ‐ Date all trial activity is completed, usually date IRB has approved closure. 5. Trial Status – Sponsor Hold – This status is used when Sponsor halts enrollment. 6. IRB – Approved: The most recent IRB continuing review approval and expiration dates. This status is updated after each continuing review. This status is never marked as the CURRENT status. Publish to Hospital Billing CRIS is linked to O2 (EPIC). There is a daily transfer of information from one system to the other. One important function of the transfer is to assist with billing compliance. Studies that involve charges for KU Hospital services, including laboratory and investigational pharmacy, MUST be flagged to publish to hospital billing. To flag a study: 1. Go to the Summary page of the study. 2. Click on [More Study Details] next to the Study Number field. The More Study Details window opens. 3. Click the checkbox for “Publish to Hospital Billing” 4. Enter your e‐Signature and click [Submit].
Add a New Patient to CRIS, Associate Patient to a Study New patients are added to CRIS via the Patient Details form. The PI and/or the PI designee (i.e. study coordinator) enters the patient data. There is only one way to add a new patient to the system. If you try to add a patient any other way, you will receive an error message. For NON‐CANCER studies, any study using hospital services OR interventional study running through the RI are required to enter patient data into the system. To add a new patient to CRIS: 1. Click Manage on the Menu Bar in the top left corner of the screen. 2. A second menu will appear after this. Under Patient menu, click [New]. This directs you to Patient Details. 3. Under Patient Details, enter: (* = Required field) a. *Patient ID: Use the MRN. If there is no MRN, use the study specific patient ID. If there is no study specific ID, use an appropriate alternate ID. Studies using hospital services are required to use the MRN in this field. i. If the subject has not been issued an MRN and it is required, request it at once. ii. NOTE: When creating a new patient record, if the subject has an MRN in the system already, it will notify you that it’s already in use. If it is, do not add the same person twice. Locate person through the Patient Search function. Check patient status on other study(ies).
CRIS V11 Page 9 of 14
4.
5. 6.
7. 8. 9.
iii. If a subject has been entered into the system, but you cannot see them, email
[email protected] and let them know the situation. iv. If there is an alternate ID for the subject that needs to be entered, use the Patient Study ID field on the subject status screen. b. First Name: c. Last Name: d. *Date of Birth: e. *Gender: Male/Female/Other/Unknown f. *Primary Ethnicity: Choose from drop down list g. *Primary Race: Choose from drop down list i. Additional: Provides the same options as Primary Race field Under Registration Details, enter: a. *Organization: defaults to your Primary Organization (think of organization as the program where you work. Most people will either be KUMC or KUCC). If the patient is part of a different organization at KUMC (i.e. SoM – Wichita or Alzheimer and Memory Program) or is at a sub‐site, change organization accordingly. Access to the record after it is created is limited to persons with access to that organization. If you change the organization from KUMC, make sure anyone who needs to see that patient data has access to the organization you designate. i. Patient Facility ID: Only for sub‐site subjects b. Provider: Physician/fellow/resident that is sending the patient for evaluation in a clinical trial (not just a general consult). Required for cancer and cancer‐related studies. c. *Survival Status: Alive/Dead/Lost to Follow‐Up i. If survival status = Dead, enter Date of Death: d. Cause of Death: Specify group/departments with access to edit patient details: LEAVE BLANK. Select a study to enter screening/enrollment details for this patient: Easiest to assign a patient to a study at this point. Select study IRB# from drop down list. a. If the study is not in the drop down list, and: i. CRA is providing administrative support; notify your CRA Project Manager immediately ii. CCRO is providing administrative support; notify your CCRO contact immediately iii. CRA/CCRO is NOT providing administrative support, notify CRIS at
[email protected] Enter your e‐Signature and click [Submit] After you click [Submit], the Patient Study Status window will open, if associating a patient with a study. See Change a Patient Status section for more information. After the patient details are saved the first time, the contact information fields will be available. For all patients affiliated with the University of Kansas Cancer Center, the patient’s Zip/Postal Code and Patient Primary Disease are required.
CRIS V11 Page 10 of 14
Searching and Editing Patient Information Patient demographics can be altered or updated after they are added to CRIS. There are two ways to locate the Patient to edit. 1. Patient Search a. Click Manage on the Menu Bar in the top left corner of the screen. b. A second menu will appear after this. Under Patient menu, click [Search]. This directs you to Patient Search. c. Enter relevant criteria for patient and click [Search] d. Patient(s) displayed in same window. Find Patient to edit. Click the icon to edit patient details. 2. Enrolled Patients a. Click Manage on the Menu Bar in the top left corner of the screen. b. A second menu will appear after this. Under Patient menu, click [Enrolled]. This directs you to Enrolled. c. Enter relevant criteria for patient and click [Search]. d. Patient(s) displayed in same window. Find Patient to edit. Click the icon to edit patient details. Once you open Patient Details, you can edit patient information. When you edit patient demographics, you are required to include a reason for change. This requirement is needed in the case of an FDA audit of the system.
Change a Patient Status In order to change a patient status, you must have access rights to view study specific patient data. 1. Click Manage on the Menu Bar in the top left corner of the screen. 2. A second menu will appear after this. Under Patient menu, click [Enrolled]. This directs you to Enrolled. 3. Search for patient. 4. Click the icon in the “Current Status” column. This opens the Enrollment Details page for that particular patient. 5. Click the [Add New Status] link. This opens the Patient Study Status window. a. Patient Status: The statuses below are listed in chronological order for a patient. Not all statuses may be applicable for a patient. Statuses should be entered in chronological order. i. Pre‐Screening: uncommon/do not use (specific to Cancer Center studies) ii. Screening: Date patient signs the first consent form, regardless of protocol registration status. If protocol requires more than one consent form, enter dates of additional consents in the notes field.
CRIS V11 Page 11 of 14
1. Screen Number, Screened By and Screening Outcome fields become available. If screening done by same person as consented the patient, person identified in “Screened By” field must match the consent form. 2. Patient Study ID: use this field to ID a study specific patient ID. 3. Enrolling Site: Organization to receive enrollment credit, usually the same as protocol treatment location. Required for Cancer and cancer‐ related studies. 4. Assigned To: Study coordinator/nurse responsible for patient trial management. Required for Cancer and cancer‐related studies. 5. Physician: Consenting physician that will receive enrollment credit. Required for Cancer and cancer‐related studies. 6. Disease Code: Patient’s primary disease as defined by the ICD‐9 code. Required for Cancer and cancer‐related studies. Screen Failure: Date patient does not meet all eligibility criteria, or is unable to participate for other reasons (i.e. patient chose not to participate after signing consent, but prior to enrollment). 1. Reason: Select most appropriate reason for screen failure from drop down menu. If ineligible, select this choice and provide description in the Notes field. 2. Status: Date patient deemed a screen failure. Enrolled: Date the patient is registered to the protocol with the sponsor or coordinating group. This occurs after all eligibility criteria are confirmed. 1. If not already done, change patient study ID to the study specific assigned ID. The patient ID remains the MRN or site generated ID. 2. This status includes the patient in study accrual counts 3. Randomization Number and Enrolled By fields become available. Enrolled By field defaults to the user. It should denote person who enrolled the subject onto the study versus the user entering the patient into CRIS. This can be the same person. Active/On Treatment: Date the first protocol therapy or intervention is administered. Use this status to specify the patient has started treatment. Active/Observation: Date first protocol procedures performed in support of observational study. Off Treatment: Date the decision to discontinue protocol therapy or intervention was made. Select most appropriate reason for discontinuation from drop down menu. 1. If Toxicity/Adverse Event, note the toxicity in the notes. 2. If Consent Withdrawn, include a comment to confirm if patient agrees to future contact for research purposes. 3. If Noncompliance/Protocol Deviation, include description in notes.
iii.
iv.
v. vi. vii.
CRIS V11 Page 12 of 14
viii. In Follow‐Up: Date short or long term follow‐up started. Usually this is the day after the off treatment date. It is not necessary to select a reason from drop down menu for this status. This status only needs to be entered once. Do not add a new status for each visit. ix. Off Study: Final date of patient contact for study related purposes. For subjects that completed all study procedures, select Study Requirements Completed from the drop down menu. DO NOT enter this status until all follow‐up, including survival status, is complete. Selecting this status will notify KU Hospital billing the subject is no longer part of the clinical trial. x. Lockdown: Optional field for when case report forms are completed in CRIS. This locks down all study data for the patient. Patient form data is no longer editable and no further data can be added. Use this status at study closure. 1. If modification/additions are needed, delete this status from the Screening/Enrollment page, make the desired changes, and then add a new lockdown status. b. *Status Date: Date based on study status chosen. Definitions for each status are listed above in i‐x. c. Enter your e‐Signature and click [Submit]
Marking Visits Complete When a study record has a calendar associated to it in CRIS, subject participation can be tracked in the system. Calendars are able to detail study visits and events that occur at each visit. After a subject completes a visit, denoting they are “Done” with the visit signifies they have completed the visit and, if applicable, associated events. This element of CRIS is useful for maintaining subject compliance with the protocol and study billing. Non‐research patients are not tracked in CRIS. Subjects that are tracked in CRIS are those that have demographic information in the system. These subjects will have signed an informed consent form or had consent waived. Subject progress is tracked by KU Hospital Billing. The Subject status and visit information is linked to billing systems. The linking serves to help identify the correct payer for a procedure/service. Editing Study Events Patient progress through the study is tracked by keeping their study status and visit information up‐to‐ date. The visit information contains all research related events that occur during study visits. To edit visit info: 1. Click Manage on the Menu Bar in the top left corner of the screen. 2. A second menu will appear after this. Under Patient menu, click [Schedule]. This directs you to the Patient Schedule form.
CRIS V11 Page 13 of 14
3. Click on the row with the patient to be updated. This opens the Protocol form containing the schedule for that specific patient. All study related visits will be listed on this screen. 4. Click the desired row to expand the visit and show all events. 5. Click [Edit Visit] to view the Edit Visit window. a. The Edit Visit window lists all events to be done during each visit. 6. Actions to take in the Edit Visit window given different circumstances: a. If the patient completed all events for the visit: i. Status = Done ii. Status Date = Date of Visit iii. Click [All] to apply to all events iv. Add a reason for change, suggested standard language: 1. Data initially omitted 2. Entry Error 3. Changed per query 4. Status change 5. Other (provide details) v. Enter your e‐Signature and click [Submit] b. If the patient completed some of the events for the visit: i. Check the box next to each event that was completed ii. Change the status to Done iii. Update Status Date with Date of Visit iv. Add a reason for the change v. Enter your e‐Signature and click [Submit] c. When events are not done: i. Check the box next to the event ii. Select Status: Not Done/Not Required/To Be Rescheduled/Suspended iii. Update Status Date with the Date of Visit or Current Date iv. Add a reason for the change v. Enter your e‐Signature and click [Submit]
CRIS V11 Page 14 of 14
