FAQs: Data Submission

Source Documents and Rave Data Entry Pre-Rave Data Submission (legacy trials)

Specimen Submission Reporting Period / Treatment Form(s)

Expectation and Institutional Performance Review (IPR) Reports

Source Documents and Rave Data Entry

  1. What do I need to do before uploading source documents in RAVE?

    a. Fully redact patient identifiers from all source documents (both within the document and the electronic file name or title of the uploaded document);
    b. Include all pages of the document, even blank pages when uploading the document;
    c. Include the SWOG patient number, initials and SWOG study number on at least one page of the source document (adding this information to the title of the .PDF file alone is not sufficient);
    d. Do not include any unique characters in the electronic file name of the document (such as "#").
    e. Do not upload any additional documents that are not specifically required for data submission in the protocol unless otherwise requested.

    Source: ORP Manual Chapter 4 Data Submission and ORP Manual Chapter 16 General Forms and Guidelines (Login with CTEP credentials required to access link). 
     
  2. Our institutional laboratory results are reported in different units than what is indicated in the Protocol (and/or Rave). Should I submit the results in Rave in the units that the reporting laboratory provides to ensure accuracy? How do I change the display units in Rave?

    Laboratory results must be reported (entered into Rave or into the CRA Workbench (for pre-Rave trials)) in the units specified on the SWOG case report form.

    Participating site staff are responsible for converting the laboratory result units prior to entering the data. All SWOG forms will specify the expected unit and most will provide an example such as xx.x. Please carefully review the requirement for laboratory units. Inaccurate data entry (wrong units entered) is one of the most common reasons that participating sites receive queries.

    For example, if the Case Report Form indicates: ANC μl (xxxx), then ANC should be reported in microliters and be entered as a 4 digit number. If the participating site enters "17" when the value in microliters is actually 1700, the patient will be coded as ineligible.

    If laboratory results are entered in incorrect units on a baseline form that is required for eligibility, the patient will be made ineligible if value does not meet the requirements (unless the participating site subsequently corrects/amends the data on the form).

    Note: SWOG Data Coordinators are not allowed to subsequently convert the laboratory result units that a participating site submitted on a form.

    Source: Instructions on each respective SWOG Case Report Form.  
  1. What do I need to do to respond to this query in Rave?

    Either change the data on the form, if appropriate, and/or provide an explanation in the "Comments" field at the bottom of the form.

    Source: ORP Manual Chapter 4 Data Submission (Login with CTEP credentials required to access link).
     
  2. I'm entering data for Cycle 2 (the previous cycle), do I need to complete the Vital Status Form?

    Yes; When entering data on a SWOG Study that uses Vital Status forms, you should complete the Vital Status form first, using the most recent last date of contact, before entering any other data in the chart.

    Even if you are reporting previous cycle data, the most recent date of contact should be entered on the Vital Status form first, before completing any study data in order to avoid queries.  You do not need to complete a Vital Status update for every date of contact when you are submitting any data (just reflect the most recent date of contact when completing the Vital Status Form).

    Source: ORP Manual Chapter 16 General Forms and Guidelines (Login with CTEP credentials required to access link).
     
  3. Patient 123456 has a target lesion that resolved. Do I need to include this lesion on the Follow-up Tumor Assessment Form?

    Yes; All disease present at baseline must be documented to ensure that response can be properly assessed. 
    •If a lesion has resolved, you still must report on the CRF that the site was assessed, including the method and date of assessment, and measurements if there are any.
    •If measurements were not obtainable, the reason for that must be clarified in the Comments section of the form.
    •If 0 is entered as a measurement, this must be initially confirmed in the Comments section that disease was assessed and that it had completely resolved as opposed to not assessed or assessed but unable to be measured.

    Source: ORP Manual Chapter 11 Response Assessment     (Login with CTEP credentials required to access link). See also: Follow-up Tumor Assessment Form.
  4. Rave requires a date to be entered into the form, however the date is unknown. How do I bypass the requirement for entering a date?

    If the exact date is unknown, and UNK is not provided as an option on the Case Report Form, then enter in 15 and explain in the comments section at the bottom of the form. 

    If the month is unknown and UNK is not an option, the enter in June then explain in the comments section at the bottom of the form.
     
  5. For purposes of data entry, does SWOG allow tumor measurements or laboratory values to be rounded?

    Yes; When rounding is used in reporting numerical digits on SWOG forms, it must be done to the nearest digit requested on the CRF (whole or decimal; round up for ≥ 5 and round down for < 5).

    • Baseline Tumor Assessment and Follow-Up Tumor Assessment Forms request target lesion measurements be reported in centimeters to the nearest tenth (e.g., 1.5 cm).
    • If the scan report provides a measurement of 2.78 cm (or 27.8 mm), it is acceptable to round the measurement as 2.8 cm.
    • Rounding is also allowed for any lab or test value related to eligibility unless otherwise noted in the protocol.

    Source: ORP Manual Chapter 16 General Forms and Guidelines (Login with CTEP credentials required to access link).
     

  6. Is the "Last Contact Date" the same as the last clinic visit date?

    Not necessarily. The LCD is the last date you can attest to the survival status of a patient. This date can be the date of a phone call, a visit to the ER or other office outside your clinic. Survival status may even be verified by a twitter update. 

See also Data Submission Guidance, Tips, and Tricks
 

Pre-Rave Data Submission (legacy trials)

  1. I'm new to SWOG and was informed that study SXXXX is a "pre-Rave" trial. If the study is not in Rave, then where do I go to submit the data?

    For pre-Rave studies, study data is submitted through the CRA Workbench (which can be accessed via the SWOG website). 
    Sites that are participating in a SWOG-led trial through another Lead-Group can access the CRA workbench at:     https://crawb.crab.org/TXWB/FormsCS/PatLookup.aspx.
     

  2. What should I know about edit checks in Pre-Rave data submission?

    If you see a red light icon, this indicates an error that must be fixed before the form can be submitted.

    A yellow light icon indicates a warning, and must be acknowledged before a form can be submitted.

    A green light icon means that the form submission was successful. 
     
  3. How do I amend a form on a pre-Rave study?

    If the form can be amended online, then click the link for the existing form to make changes.  Do not create a new form. The new form will not be recognized by the system and can prevent other forms from being submitted successfully.
     
  4. I need to amend a form on a pre-Rave study, however I do not see a way to amend the form online. What do I do?

    Some forms were originally submitted in paper format and are, therefore, not able to be amended online (such as the Confirmation of Registration form).  Amendments to these forms must be done manually (via written changes that are then faxed or emailed).

    Print the form and amend it by hand. Then to submit the amended form: Either fax or scan and email the amended form.  Write "amended" at the top of the amended form(s), and mark (or circle) the amended data. Draw a line through the incorrect entry, write the correction next to it and initial the change.  
     

  5. With OPEN, Rave, and all the tools in CTSU, why is the CRA Workbench still relevant?

    The CRA Workbench is the only data entry mechanism for pre-RAVE studies.  Moreover, the CRA Workbench reports include patients on both RAVE and pre-RAVE studies. The CRA Workbench includes critical SWOG-specific information such as CRA Manual, Best Practices, and Policies. This information is maintained by SWOG SDMC staff, so the tools and resources that are included are based largely on CRA feedback and requests. 

    Sites that are participating in a SWOG-led trial through another Lead-Group can access the CRA workbench at: https://crawb.crab.org/TXWB/FormsCS/PatLookup.aspx.

Specimen Submission

  1. The mandatory tissue collection at completion of Cycle 2 was completed as per standard of care, however there was insufficient tissue to submit the mandatory sample. How do I resolve the query for the tissue submission?

    The Specimen Tracking System (STS) is used for both those specimens being submitted and those that are not being submitted (such as in cases of insufficient sample for submission). It’s important to log specimens not being submitted in order to resolve expectations. Note: This may affect eligibility on some studies.

    Source: Specimen Tracking System Training Module with demo (also available in Spanish) (login with CTEP credentials required); STS Written Instructions; and SWOG Best Practices document.
    For information on Specimen Collection: See also: SWOG Protocol Conduct FAQs: Specimen Collection.
     
  2. Patient 246810 did not have a biopsy performed at completion of Cycle 2 of treatment per standard of care, however there is a required tissue specimen submission indicated in the Specimen Tracking System at this timepoint. Do I need to do anything?

    Yes; use the "Notify that Specimen Cannot be Submitted" link in the Specimen Tracking System to document the reason that the specimen is not being submitted. See also: How to complete a notification that specimens cannot be submitted in the SWOG Specimen Tracking System (STS) (or the Spanish-language training presentation, login with CTEP credentials required).

    Source: SWOG Protocol Section 15.
     
  3. The protocol requires submission of 15 slides, however only 10 slides were available. How do I document this in the Specimen Tracking System?

    Refer to the STS Partial Shipment instructions.

Reporting Period / Treatment Form(s)

  1. What do I need to know about reporting periods?

    •  The reporting period start date is Day 1 of the cycle.
    •  The reporting period end date is day 1 of the next cycle, unless final cycle, then it is last day of treatment.
    •  There should be no gaps in reporting periods.
     
  2. How do I know what dates to include on the treatment form for the reporting period?

    Reporting period start and end dates should reflect the length of the cycle, regardless of treatment and reflect the first day the patient receives treatment and Day 1 of the next cycle. Unless otherwise specified in the instructions of the Treatment Form, reporting periods should reflect the first day the patient received treatment on the cycle and extend to the first day of the next cycle. Often, reporting period dates and treatment dates are not the same.

    Source: Standard form instructions and Help Text fields
     
  3. What do I need to know about entering treatment dates on the Treatment Form?

    Treatment dates should reflect the first and last day of actual treatment given. If a date is entered, this  implies that treatment was given on that day.
     
  4. Patient 5678910 experienced Gr. 3 toxicity on Day 1 of treatment for Cycle 2. Treatment was held and no further treatment was given during Cycle 2. How do I report this on the treatment form?

    If only 1 day of treatment is given, the first and last days of treatment should be the same date.
     
  5. I don't know what the treatment form is asking in field "X". Who can clarify this?

    If unsure what a form or field is asking, you may be able to locate clarifying information on the form/in Rave: Refer to the Form instructions, Look for and read the "Help" text which is available for some of the form fields in Rave, and then reach out to the Data Coordinator(s) for the respective study via e-mail distribution list or telephone for clarification.

    Data Coordinator email addresses are:
    BreastQuestion@crab.org
    CancerControlQuestion@crab.org
    GIquestion@crab.org
    GUquestion@crab.org
    GYNquestion@crab.org
    LeukemiaQuestion@crab.org
    LungQuestion@crab.org
    LungMAPquestion@crab.org
    LymphomaQuestion@crab.org
    MelanomaQuestion@crab.org
    MyelomaQuestion@crab.org
    RareTumors@crab.org
    SWOGComboMATCHquestion@crab.org
    SWOGiMATCHquestion@crab.org
    SWOGMyeloMATCHquestion@crab.org

    Source: Query Reports link accessible from the CRA Workbench. (Login with CTEP credentials required to access link). 
  6. What is the defined reporting period for adverse events data submission?

    Adverse Events should be assessed at the end of every cycle, ideally on Day 1 of the next cycle. On a given cycle, adverse events identified from the time of the first treatment on that cycle until the beginning of the following cycle must be reported. The “Date of the most recent adverse event assessment” should be a date equal to or more recent than the “Date of last treatment” on that cycle. All adverse events occurring prior to initiation of the next cycle must be reported. Furthermore, when labs are drawn on Day 1 of a cycle and prior to the patient receiving study drug on that cycle, any abnormal laboratory findings should be reported on the AE Form for the prior cycle since they pertain to treatment from the previous cycle.  See also: FAQs: Adverse Events, Serious Adverse Events, and External Safety Reports | SWOG.

    Source: ORP Manual Chapter 15 General Forms and Guidelines     (Login with CTEP credentials required to access link).

Expectation and Institutional Performance Review (IPR) Reports

  1. Why is our institution out of compliance on the IPR report?

    Institutions are considered out of compliance if any of the following apply in a given month:
    1. 10% (or more) of patients registered in the last 13 months is missing baseline (Initial Forms Set) data,
    2. Any patients registered > 13 months ago is missing baseline (Initial Forms Set) data,
    3. 5% (or more) of patients registered are missing post-baseline forms,
    4. 15% (or more) of patients registered are missing current Vital Status updates in the EDC,
    5. 10% (or more) of expected specimens were not logged/shipped in Specimen Tracking in the last 13 months,
    6. Any specimens expected to be logged/shipped in Specimen Tracking > 13 months ago.