REGISTERING A PATIENT Patient Eligibility It is important for the institution staff to review all eligibility criteria and follow-up requirements. A patient failing to meet all protocol eligibility requirements may not be registered. A patient cannot be canceled from a protocol once he or she is registered, regardless of the surrounding circumstances. Typically, in older studies, once a patient number is assigned, the patient is followed for life. In recent studies this has become less stringent and follow up may be required for a limited number of years. Always refer to section 14 of the protocol to verify how long you must follow the patient. The following steps should be taken to prepare for the registration: 1. Review eligibility per Section 5.0 of the protocol. 2. Review all amendments which could affect eligibility. 3. Confirm that all legal requirements have been met. Assure that the protocol has undergone IRB approval within the last year and note IRB approval date. Verify that the informed consent has been signed. 4. Verify that all appropriate pretreatment tests have been completed within the time frame defined in the protocol. Chapter 12 - Page 1 ORP Manual Version 3.0
Timing Guidelines for Prestudy Labs, Measurements and H & P These guidelines may differ on a study-specific basis and will be clearly stated in the protocol. In the absence of study-specific guidelines, the following guidelines will be strictly applied. To be completed within 28 DAYS prior to registration * Blood work or other body fluid analyses (urinalysis, creatinine clearance) required for determination of eligibility. * X-rays, scans or physical examination utilized for tumor measurement on Phase II or Phase III studies. * History and Physical To be completed within 42 DAYS prior to registration * Baseline exams used for screening (e.g., audiogram, PFT) other than blood or body fluid analysis. * X-rays and scans of non-measurable disease or of uninvolved organs on Phase II or Phase III studies. To be completed within 56 DAYS prior to registration * X-rays, scans, ultrasounds, etc. used to establish disease free status on adjuvant studies. 5. Check the anticipated treatment start date. Do not register a patient if treatment has already started or if treatment is anticipated to begin more than three working days following registration unless the protocol allows otherwise. 6. When pathology review is required, confirm with the pathologist that the materials are available for submission. 7. When radiation therapy rapid review is required, notify the radiation therapy department that materials must be submitted within 48 hours following the first treatment fraction and that the treatment guidelines in the protocol must be followed. If a pre-registration radiation therapy consult is required, details will be included in the eligibility section of the protocol. 8. Order investigational drugs, as appropriate. After a protocol with an investigational new drug is approved by an institution's IRB, some studies will allow the institution to order a "loading dose" from the NCI (enough for one patient), even though the institution has not yet put a patient on protocol. Section 3 of the protocol will have ordering instructions. Chapter 12 - Page 2 ORP Manual Version 3.0
9. Check protocol sections 12 and 15 for any special requirements. Some studies allow specimen submission prior to registration. These can be logged and shipped in the SWOG Specimen Tracking System and a SWOG patient number will be assigned. It is imperative to use this SWOG patient ID number during the registration in the Oncology Patient Enrollment Network (OPEN) system. 10. Verify that the patient is scheduled to return to the institution for follow-up as required. Refer to the Study Calendar in the protocol for scheduling guidelines. In calculating days of tests and measurements, the day a test or measurement is done is considered day 0. Therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered Day 28. This allows for efficient patient scheduling without exceeding the guidelines. If Day 28, 42 or 56 falls on a weekend or holiday, the limit may be extended to the next working day. The SWOG Data Operations Center will not make exceptions to the eligibility criteria in the protocol without a written amendment to the protocol from the Operations Office. Amendments must be recommended by the study chair, approved by the disease committee chair, the Headquarters Executive Officer, the statistician of record, and the NCI. Once approved at all levels, the amendment to the protocol and revised checklist are circulated to the Group. No one in the Group is authorized to make an exception to eligibility criteria unless an error is discovered in the protocol relating to the exception. Section 5.0 of the Protocol Section 5.0 of the protocol is designed to assist the oncology research professional in identifying an eligible patient. Patients must meet all criteria prior to completing the registration. 1. Using the patient's medical record, answer the eligibility and exclusion questions. Record laboratory results using actual laboratory report. Review the pathology report to confirm the histology. Read the patient's medical history to confirm eligibility. Review results of diagnostic tests to confirm stage of disease. Verify that all required tests were performed within the correct time frame. Indicate the date of laboratory values, tumor measurements, dates of diagnosis or scans, even if a line is not provided for this information. This provides a cross-reference to the information you obtained in completing the onstudy form, which is especially helpful in locating data for quality assurance audits. The answers to these questions asked at time of registration are viewed as an oath that the patient meets the criteria for entry to the study. When a patient does not qualify for entry to the study based on the answers, do not attempt to register the patient; no exceptions are made to the protocol eligibility criteria. Chapter 12 - Page 3 ORP Manual Version 3.0
The Study-Specific Registration and Onstudy Forms The majority of SWOG protocols contain study-specific registration and prestudy or onstudy forms. The registration form must be completed prior to initiating the registration. Section 5.0 of the protocol is to be used as a worksheet to ensure that all eligibility criteria have been satisfied. 1. Complete all information requested on the Registration Form: the patient's initials, zip code of residence, institution and investigator numbers, date patient signed the informed consent and HIPAA authorization and the projected start date of treatment. 2. The Registration Form must be signed and dated by the treating investigator prior to registration. This form is not submitted to SWOG, but must be in your records for review by auditors. 3. Using the patient s medical record and eligibility criteria per Section 5.0 of protocol, complete the study-specific onstudy form. In addition to demographic data, sections may include patient characteristics, disease description, prior treatment, stratification and descriptive factors. OPEN Registration Guidelines Patients must be registered prior to initiation of treatment, no more than three working days prior to the planned start of treatment unless otherwise stated in section 13.1 of the protocol. Effective October 1 2009, registrations are to be performed via the Oncology Patient Enrollment Network (OPEN). The individual registering the patient must have completed the appropriate SWOG Registration Worksheet. The completed form must be referred to during the registration but should not be submitted as part of the patient data. OPEN will also ask additional questions that are not present on the SWOG Registration Worksheet. The individual registering the patient must be prepared to provide answers to the following questions: a. Institution CTEP ID b. Protocol Number c. Registration Step d. Treating Investigator e. Credit Investigator f. Patient Initials g. Patient s Date of Birth h. Patient Social Security Number (SSN is desired, but optional. Do not enter invalid numbers.) i. Country of Residence j. ZIP Code k. Gender (select one): Female Gender Male Gender Chapter 12 - Page 4 ORP Manual Version 3.0
l. Ethnicity (select one): Hispanic or Latino Not Hispanic or Latino Unknown m. Method of Payment (select one): Private Insurance Medicare Medicare and Private Insurance Medicaid Medicaid and Medicare Military or Veterans Sponsored NOS Military Sponsored (Including Champus & Tricare) Veterans Sponsored Self Pay (No Insurance) No Means of Payment (No Insurance) Other Unknown n. Race (select all that apply): American Indian or Alaska Native Asian Black or African American Native Hawaiian or other Pacific Islander White Unknown All site staff will use OPEN to enroll patients to this study. OPEN is a web-based application and can be accessed at https://open.ctsu.org, or from the OPEN tab on the CTSU members side of the website at https://www.ctsu.org, or from the OPEN Patient Registration link on the SWOG CRA Workbench. a. Prior to accessing OPEN site staff should verify the following: All eligibility criteria have been met within the protocol stated timeframes. Site staff should refer to Section 5.0 to verify eligibility. All patients have signed an appropriate consent form and HIPAA authorization form (if applicable). b. Access requirements for OPEN: Site staff will need to be registered with CTEP and have a valid and active CTEP-IAM account. This is the same account (user ID and password) used for the CTSU members' web site. To perform registrations on SWOG protocols you must have an equivalent 'Registrar' role on the SWOG roster. Role assignments are handled through member@swog.org. Note: The OPEN system will provide the site with a printable confirmation of registration and treatment information. Please print this confirmation for your records. c. Further instructional information is provided on the OPEN tab on the CTSU members side of the website at https://www.ctsu.org or at https://open.ctsu.org. For any additional questions contact the CTSU Help Desk at 1-888-823-5923 or ctsucontact@westat.com. Chapter 12 - Page 5 ORP Manual Version 3.0
Registrations must take place no more than three working days prior to the planned start of treatment unless otherwise stated in section 13.1 of the protocol. Such allowances sometimes are made for studies requiring time for ordering protocol specific agents or in which surgery or radiation therapy are the first treatment modalities following registration. This includes studies requiring placement of a Hickman catheter or portacatheter. However, actual scheduling of radiation therapy or surgery should take place immediately following registration. If scheduling cannot be done immediately (e.g., patient is unsure when he/she will be available, surgeon is out of town for an extended time), the registration should be delayed. Chapter 12 - Page 6 ORP Manual Version 3.0