FAQs: Protocol Conduct

IRB REVIEW / SITE INITIATION    Participant Consent    Eligibility   

Treatment    Remote / Telehealth Visits    Participant Transfers   

Disease Assessment    Participant Follow-up    Specimen Collection

General

1. I cannot access CTSU; I am receiving an error when I try to log in. What should I do? Who do I contact for help?
   
   SWOG is not able to assist participating sites in resolving login credentials. Persons with an existing CTEP ID, can verify or reset CTEP login credentials via the IAM (Identity and Access Management Website) or by contacting ctepreghelp@ctep.nci.nih.gov for assistance. If your CTEP IAM ID and password is working correctly and you are still experiencing difficulty accessing CTSU systems, please contact the CTSU Help Desk at 1-888-823-5923 or via email at ctsucontact@westat.com for assistance.
   
   Source: CTSU FAQs.
    
2. I have questions about the conduct of the protocol. Who do I contact?
   
   Refer to the Contact Information Page included near the beginning of all SWOG-led protocols. For general topic-related distribution lists, see: General Contact Information for SWOG-led Protocols.
    
3. I'm not able to find the Patient-reported outcome questionnaires posted on the CTSU protocol abstract page. The questionnaires are not included in the Master Forms Set with the other forms. Can you send them to me or where do I locate the questionnaires?
   
   All participant-facing documents and forms either given or read to participants (including quality of life questionnaires and participant surveys) are posted under the CIRB-Approved documents section of the CTSU protocol abstract page (Due to the NCI single document posting rules the questionnaires are not included in the Protocol Related Documents section under "Case Report Forms".)
   
   Source: CTSU Document Posting for CIRB-Reviewed Studies - Understanding Document Types (Login to www.ctsu.org with CTEP credentials required to access link).  
    
4. When and where can I find CIRB-approved materials for use when introducing a participant or family member to a trial?

   Starting in the spring of 2022, all new trials opened by SWOG will have a CIRB-approved patient-friendly trial summary available at (or shortly after) activation.

   These summaries are built around a set of questions selected by a team of patient advocates and health education experts to provide participants key initial information that will help them decide whether they want to learn more about a given study. The summaries are written at a middle school level to match the average literacy level of the American public.

   These documents are available as printable PDFs on www.ctsu.org. On the CTSU page for a given protocol, go to the Documents tab, then the CIRB Approved Documents tab. The summary is typically under a Participant Materials heading or a Recruitment heading.

   Summaries also publicly accessible on the SWOG website. You can send your participants to swog.org/SXXXX, where SXXXX is the SWOG trial number (e.g., swog.org/S2013). You can also download a printable PDF version of the summary from that page.

   These patient-friendly summaries initially will be available only for newly launched trials, but over time they will also be developed for the backlog of currently active SWOG trials.

IRB Review/Site Initiation

1. Our IRB requires the Investigator's Brochure for this SWOG study, however I didn't find this posted on the CTSU protocol abstract page. How do I obtain the IB?
   
   See Section 3 of the protocol to determine how to proceed.
   
   For protocols conducted under a CTEP-held IND:
   The current version of the Investigator Brochure for the agent will be accessible to site investigators and research staff through the NCI CTEP Pharmaceutical Management Branch (PMB) AURORA application: https://ctepcore.nci.nih.gov/aurora/login.  Access to AURORA requires the establishment of a CTEP Identity and Access Management (IAM) account and the maintenance of an “active” account status and a “current” password. Questions about IB access may be directed to the PMB IB coordinator via e-mail (IBCoordinator@mail.nih.gov).
   
   For protocols conducted under SWOG-held INDs:
   Unless otherwise stated in Section 3.0 of the protocol, SWOG utilizes Section 3.0 of the protocol as the IB, per SWOG Policy 15. Most institutions accept SWOG Policy 15 along with reference to the statement at the beginning of the respective protocol Section 3 as the IB. In rare cases where the institution still requires the IB, SWOG will convey the request to the industry collaborator. The industry collaborator may require the participating site to execute a confidentiality disclosure agreement directly with the company to obtain the IB. Questions about Investigator's Brochures may be directed to the contact information listed in Section 3 of the protocol or protocols@swog.org.
   
   Source: Current version of respective SWOG protocol (Section 3); SWOG Policy 15; CTEP/PMB Investigator Brochure FAQ document.
    
2. Where do I find/obtain a copy of the FDA IND approval letter for a study with a CTEP-held IND?

   For the purposes of providing IND documentation to your institutional IRB, CTEP requests that you contact the Lead Protocol Organization (or Lead Group) to obtain a copy of the NCI Notice of Protocol Approval Letter for the trial. The Protocol Approval Letter identifies the DCTD/NCI IND(s) to which the protocol is filed and a statement that the protocol has been submitted to the Food and Drug Administration as an amendment to the NCI-sponsored IND(s) for the investigational agent(s). 
   
   For SWOG-led protocols, please email: protocols@swog.org to request a copy of the NCI Notice of Protocol Approval Letter. 

Participant Consent

1. What amount of time can pass between consent and registration to the study?
   
   Generally, no more than 30 days. If there is a substantial delay from the time the participant signs consent and is enrolled in a study (> 30  days), it is recommended that the information contained in the consent form be reviewed with the participant prior to initiating any research procedures and the discussion documented in the  research record. The participant must be reconsented and/or verbally informed prior to registration if there  have been any significant updates to the consent (new study design, added risk, etc.). Reconsent is not  required if there are no changes or only minor changes to the consent.
   
   Source: Expectations of a Successful Regulatory Audit.
    
2. Revision X was just distributed. Do I need to reconsent participants (or participants on Arm X)?
   
   Please review the Cover Memorandum distributed with the SWOG protocol revision. Note: SWOG cover memoranda include Action Codes (for required IRB review and participant notification) and Key Updates sections at the onset of each memorandum.
   
   If NCI and/or SWOG determines that participant notification is required, the cover memorandum will indicate one of the following at the onset of the form (now usually included under the "Action Codes" header on Page 1 of the memorandum). Then, the complete instructions (pertaining to which participants must be informed, and including the notification deadline, process, and whether accrual must be suspended until the revised informed consent document is implemented) will be included at the very end of the SWOG Revision Cover Memorandum under headers "Participant Notification and Use of Consent Addendum" and "Regulatory Instructions."
   
   Action Codes
   ( ) Participants Must be Informed*
   ( ) Formal Re-Consent Required*
   ( ) Verbal notification allowed
       ( ) Consent Must Be Amended*
       ( ) No Registration Allowed Until IRB Review*
   * See “Participant Notification and Use of Consent Addendum” and “Regulatory Considerations” instructions below.
   
   If NCI and/or SWOG determines that the changes to the informed consent document do not require participant notification, then this will be indicated under the "Key Updates" section on Page 1 of the SWOG Revision Cover Memorandum.
   
   Key Updates
   ( ) Informed Consent changes
       ( ) Participant notification not required
   
   If the study is a CIRB-approved study, the Participant Notification and Use of Consent Addendum instructions will also be included in the CIRB Amendment Review Form posted on the CTSU website at www.ctsu.org.
   
   Source: SWOG Cover Memoranda (attached to each revision to a SWOG protocol). If applicable, CIRB Amendment Review Form.

3. Participant 5678910 withdrew consent to participate in study SXXXX. This means that I can no longer submit follow-up data on the participant, correct?
   
   Withdrawing consent to participate in a study does not necessarily mean the participant also withdraws consent to being followed.
   
   If a participant withdraws consent after registration to the study, the participating site must discuss with the participant whether:
   *he or she no longer wishes to be treated per protocol;
   *he or she no longer wishes to be followed per protocol, or
   *he or she no longer wishes to be treated nor followed per protocol (both).
   
   The participating site must clearly document the distinction in the participant's research record and on the Off Treatment Notice or Follow-Up Form subsequently submitted in Rave.
   
   Source:  SWOG Best Practices document; SWOG Policy 30; ORP Manual v6.0 Chapter 10 Closing Out Studies for Follow-up  
   (Login with CTEP credentials required to access ORP Manual link).  

Eligibility

1. Participant 13579 was determined to be ineligible after registration, however the treating investigator wants to keep him on protocol treatment. Is this allowed per protocol?
   
   The participant may start/continue treatment provided that the reason that the participant was deemed to be ineligible does not pose additional risks for the participant.  NOTE: All safety monitoring and follow-up procedures and follow-up data submission is still required.
   
   Source: SWOG Best Practices document.
2. Section 5 says PET-CT is required within 42 days of registration, however our participant won't be back in clinic until 45 days after the PET. What can we do to register this participant?
   
   Per NCI policy SWOG is unable to grant eligibility waivers of any kind (eligibility criteria are specified in Section 5 of SWOG protocols). All required baseline eligibility assessments must be performed prior to participant registration to the protocol and within the timeframes specified in SWOG protocol Section 5. With this consideration, the best option is likely to reschedule the clinic visit in order to conduct all required baseline assessments (H&P, PS, Toxicity Assessment, Laboratory assessments) within the 42-day and other applicable protocol windows.
   
   Source: Current version of respective SWOG protocol (Section 5).
    
3. Participant (ID 123456) is participating in an NCTN study that involves investigational agents and wants to receive the Jynneos Monkeypox Vaccine. The protocol indicates that "live vaccines" are not permitted while on study.  Is this an allowable vaccine?
   
   Although the Jynneos Monkeypox Vaccine may be considered a live virus vaccine, it is not considered a live virus vaccine in terms of eligibility or administration in CTEP IND clinical trials. Therefore, eligibility criteria in CTEP IND trials excluding participants who have received a live virus vaccine do not apply to those participants who have received the Jynneos Monkeypox Vaccine and administration of this vaccine during the conduct of a CTEP IND trial would not result in a protocol deviation for that reason. Please see the NCI Guidance for Administration of the Jynneos Monkeypox Vaccine and Tecovirimat to Study Participants on CTEP IND Studies Memorandum for additional information.
   
   Source: NCI Guidance for Administration of the Jynneos Monkeypox Vaccine and Tecovirimat to Study Participants on CTEP IND Studies.

Treatment

1. Participant 123456 was due for Arm 1 Cycle 2 / Day 15 on Thanksgiving 11/26. Day 15 was deferred until 11/30 since the office was closed on 11/26. Can you please advise if any allowable treatment windows exist to accommodate holidays?
   
   Unless indicated otherwise in the protocol, SWOG guidelines (as indicated in the SWOG Best Practices document) outline allowable windows for scheduled procedures and assessments (treatment administration, toxicity assessment for continuous treatment, disease assessment, specimen collection and follow-up activities). Please note that the allowable best practices windows vary dependent upon the cycle duration and frequency of treatment or follow-up visit interval.
   
   Source: SWOG Best Practices document.
    
2. After seeing the participant (ID 12345) today, he will be taking vacation and will miss treatment during that time. For first treatment, he wants to delay by 1 day. I am not able to locate an allowable treatment window within the protocol other than requirement for removal from treatment. For the second, treatment will be delayed by about 1 month (33 days).
   
   Section 7.4 of the states that treatment delay for any reason > 42 days is a criteria to remove participant from protocol treatment.  We recognize that these will be protocol deviations. Does this affect the participant’s participation in the clinical trial?   Is any further action necessary?  
   
   Although there is not a window posted within the protocol or treatment calendar, the first delay of < 3 days is minor and within allowances of SWOG best practices unless otherwise specified in the protocol. Document the reason for the delay.
   
   The second delay of about 1 month would be a major deviation but likewise, document in the research record that the delay is due to participant choice. The study chair(s) may have additional feedback about this longer delay, as is pertinent to participant care.
   
   If protocol is not clear about allowances or doubt as to what to report, contact: qamail@swog.org and treatment (study chair) email listed on the protocol contact page.
   
   Source: Sections 7 and 9 of the respective SWOG protocol; SWOG Best Practices document.

3. Is the treatment calendar based off of the registration date, the first day of treatment, or the most recent treatment date (dose delay)? I'm trying to determine when participant's next MRI needs to be performed to be done within the protocol window.
   
   Treatment schedules/calendars vary per protocol. Please carefully review SWOG protocol Sections 7, 8, 9, and 14.
   
   SWOG protocols will usually base required follow-up timeframes from either the date of registration or the date of randomization to treatment (as specified in one or more of the following Sections: Section 7 (treatment/protocol procedures), Section 9 (calendar) footnotes, and/or Section 14 (data submission)). SWOG protocols will specify in protocol Section 8 as to whether the calendar is fixed (and doses will be considered held or missed) or adjusted due to treatment delays. That is, Section 8 will specify if the next treatment date after a missed or held dose should occur at planned/fixed timeframe or reset the calendar based upon toxicity resolution date. SWOG protocols will also usually maintain fixed timepoints for disease assessments, regardless of treatment or dose delays, however this is also variable per protocol and will be specified in Sections 7 and/or Section 9 (footnotes to the calendar).
    
4. McKesson shipped investigational agent ABC123 for SXXXX (a SWOG-held IND study) to our site for participant (ID 246810), who went off-protocol treatment on 3/3/22 due to toxicity. Participant (ID 123456) was registered today and randomized to the same arm. Section 3 of the protocol indicates that the ABC123 investigational agent drug supply is not participant-specific. Who do we contact if we have questions about how to submit subsequent drug orders for Participant 123456 and to approve the transfer of ABC123 from Participant 246810 to Participant​​​​​​​ 123456?
   
   Review the Section 3 of the respective section protocol for the appropriate contact for drug accountability and transfers in Section 3 of the protocol. Questions pertaining to drug transfers on protocols conducted under a SWOG-held IND should be directed to: qamail@swog.org.
   
   Source: Current version of respective SWOG protocol (Section 3).
5. Participant​​​​​​​ (ID 789101) has is on the investigational treatment arm of an NCTN study and has Monkeypox. Can we administer the antiviral drug tecovirimat (TPOXX) to treat MonkeyPox?
   
   Please see the CDC reference “Information for Healthcare Providers on Obtaining and Using TPOXX (Tecovirimat) for Treatment of Monkeypox” and additional information available from the FDA via links in the NCI Guidance for Administration of the Jynneos Monkeypox Vaccine and Tecovirimat to Study Participants on CTEP IND Studies Memorandum. As per the guidance document, physicians should review and consider the concomitant medications that their study participants are taking before prescribing tecovirimat.
   
   Source: NCI Guidance for Administration of the Jynneos Monkeypox Vaccine and Tecovirimat to Study Participants on CTEP IND Studies.
6. Participant​​​​​​​ (ID 123456) is participating in an NCTN study that involves investigational agents and wants to receive the Jynneos Monkeypox Vaccine. The protocol indicates that "live vaccines" are not permitted while on study.  Is this an allowable vaccine?
   
   Although the Jynneos Monkeypox Vaccine may be considered a live virus vaccine, it is not considered a live virus vaccine in terms of eligibility or administration in CTEP IND clinical trials. Use of the Jynneos Monkeypox Vaccine is per investigator discretion. However, CTEP does recommend that all study participants who are determined to be at high risk for monkeypox infection maintain a high level of awareness and be vaccinated, unless otherwise contraindicated. Where possible, vaccine administration should be timed as indicated in the NCI Guidance for Administration of the Jynneos Monkeypox Vaccine and Tecovirimat to Study Participants on CTEP IND Studies Memorandum.
   
   Source: NCI Guidance for Administration of the Jynneos Monkeypox Vaccine and Tecovirimat to Study Participants on CTEP IND Studies.
    

Remote / Telehealth Visits

1. When can a telehealth visit be substituted for an in-person visit for situations?
   
   Sites are encouraged to consult the study protocol to determine whether telehealth visits are permitted for a given study. The use of telehealth is study-specific and must align with protocol guidance regarding which visits are eligible for remote conduct.
   
   Each study evaluates the appropriateness of telehealth for individual visit types. Telehealth visits are not permitted for visits that involve in-person procedures such as treatment administration, protocol-specified endpoint assessments, physical examinations, or specimen collection.
   
   Telehealth visits are generally limited to situations where clinical safety, data integrity, and protocol compliance can be maintained through remote communication. In many protocols, this applies most commonly to off-treatment, post-progression follow-up visits that involve activities such as collecting survival status, patient-reported outcomes, or other non-invasive data points.
   
   Sites should review the protocol carefully and contact the study team with any questions about whether a visit can be conducted via telehealth.
    
2. When is Remote Consent Allowed?

   Sites are encouraged to consult the study protocol to determine whether remote consent, including eConsent and eSignature, is permitted for a specific study. If allowed, remote consenting must be conducted in accordance with the site's institutional policies and procedures, and applicable regulations.

   Participating sites within the United States must also follow the NCI Central Institutional Review Board (CIRB) Standard Operating Procedures (SOPs) related to remote consent, eSignature, and eConsent. These SOPs can be found at: https://www.ncicirb.org/about-cirb/sops.

   Sites should ensure they are in compliance with all applicable requirements before implementing remote consent processes.
    

Participant Transfers

1. Site Fabulous Cancer Care has a participant who is enrolled and still being treated on SXXXX. The participant is relocating to another state where Site Excellent Cancer Care also has SXXXX. open. What should Site Fabulous do to facilitate the participant transfer to Site Excellent?
   
   a. Contact Site Excellent (receiving site) to confirm that they can accept this participant transfer;
   b. Site Fabulous (transferring site) should ensure all data expectations and outstanding queries are resolved prior to initiating the participant transfer to Site Excellent; and then
   c. Site Fabulous will initiate a participant transfer request in CTSU’s Transfer and Update Module (T&UM) to Site Excellent.
   
   Source: Open T&UM Quick Reference Site User Guide and Patient Transfer Navigation link on the SWOG CRA Workbench.
   (Login to www.ctsu.org with CTEP credentials required to access above links).  

Disease Assessment

1. Study SXXXX utilizes RECIST criteria for disease assessment. Per the RECIST criteria, the participant meets the definition for progression, however the Treating Investigator feels that the participant hasn't truly progressed and is still receiving clinical benefit on the protocol treatment. Is there an exception to be implemented so that the participant does not need to come off protocol treatment?
   
   Progression is determined via the criteria indicated in Section 10 of the respective protocol (in the above case: RECIST criteria). If the participant meets the criteria for progression indicated in protocol Section 10, then the data submission must document that the participant has progressed, even if the Treating Investigator feels the participant is receiving clinical benefit. For most SWOG treatment protocols, if the participant progresses, then the participant must come off protocol treatment.
   
   Some SWOG protocols allow the participant to remain on study post-progression. If this allowance is indicated in Section 7 of the protocol, then the participant may remain on protocol treatment after progression provided that any associated protocol criteria for continued treatment are met; however, the progression must still be reported on the Follow-Up Tumor Assessment form. If there is a suspicion of progression but not confirmed (again, addressed in RECIST criteria), the participating site should note the suspected progression in the Comments field of the Follow-up Tumor Assessment Form and continue per protocol.
   
   Source: Sections 10 and 7 of the respective SWOG protocol.

Participant Follow-up

1. Participant​​​​​​​ 246810 is no longer coming into clinic despite several follow-up calls to schedule her follow-up appointments. Can I declare her as lost-to-follow-up?
   
   Participants may be declared as "lost to follow-up" on a SWOG-led study if the last contact date for the participant has exceeded two (2) years, documented at least three (3) telephone attempts to contact the participant and/or a certified letter to the last known address has either been returned, or not answered.
   
   To notify the SWOG Statistics and Data Management Center that your site has a participant that meets the above criteria for "lost to follow-up":
   
   For studies using Rave: Use the ‘Add Event’ tool on the Subject Summary page in Rave.
   
   For pre-Rave trials: Use the "Lost to Follow-Up" form, accessible from the CRA Workbench, under “Tools of the Trade.
   (Login with CTEP credentials required to access link).  
   
   Source: SWOG Policy 30 

Specimen Collection

The following information is relevant to specimen collection for submissions to all laboratories. For additional FAQs relevant to collection and submission of specimens to the SWOG Biospecimen Bank, please refer to: FAQs: Specimen Submissions to the SWOG Biospecimen Bank.

1. There's an ongoing blood specimen collection tube shortage and the tube required for use in the SWOG protocol is backordered. What do I do?
   
   Please see the SWOG Memorandum: Blood Specimen Collection Tube Shortage Guidance.
    
2. Protocol SXXXX indicates that we are to collect ten mL of blood in two, 5-mL purple-top EDTA tubes (which are institutionally-supplied, per protocol). Participant 1357911 will be in clinic this afternoon and we are entirely out of purple-top tubes (in any collection volume). We do have a supply of pink-top EDTA tubes. Who do I contact for approval to use pink-top tubes for this collection?
   
   For questions pertaining to utilization of alternate collection tubes, delayed specimen collection or submission, or specimen collection procedures contact the contact the Translational Medicine Chair indicated on the title page of the protocol.
    
3. Does SWOG supply specimen collection kits for all studies and types of specimen collection?
   
   No. It is important to review SWOG protocol Section 15 to determine if collection kits are being supplied. SWOG protocols commonly utilize institutionally-supplied collection materials (e.g., for FFPE tissue slide preparation, EDTA, SST, heparin, and other collection tubes that participating sites commonly have in stock as part of regular institutional activities). For protocols that involve specimen submissions, whether or not specimen collection kits are being supplied will be indicated in SWOG protocol Section 15.
    
4. How do I order specimen collection kits?
   
   It is important to review SWOG protocol Section 15 to determine if collection kits are being supplied.
   
   SWOG protocols may utilize institutionally-supplied collection materials. 
   
   If collection kits are being supplied, there may also be multiple methods (different suppliers) of specimen collection kits (across protocols or within a single SWOG protocol). SWOG protocols may also utilize industry-supplied collection kits, as specified in Section 15 of the SWOG protocol.
   
   In event that the protocol Section 15 indicates that specimen collection kits may be ordered by using the SWOG Biospecimen Bank Management Application, then the current link to the SWOG Biospecimen Bank Management Application is: https://kits.bpc-apps.nchri.org/Auth/Login?ReturnUrl=%2F. For questions pertaining to specimen collection kits that are indicated in the SWOG Protocol Section 15 as supplied by the SWOG Biospecimen Bank, contact: bpcbank@nationwidechildrens.org.
   
   See also: FAQS: Specimen Submissions to the SWOG Biospecimen Bank.