FAQs: Quality Assurance
Record Retention Study Closure Delegation of Authority
Protocol Deviations AUDITS Electronic Signatures
- We are running out of room and are wondering how long we need to keep patient charts and protocols for closed studies.
The Record Retention Guidance document describes when it is acceptable to destroy research records including IRB records, investigational agent records, and patient records. The report "List of Protocols with No Required Follow-up" available on the CRA Workbench provides a mechanism for informing institutions of the specific record retention requirement for each of our studies.
During the interim until records may be destroyed, records may be scanned and stored electronically as long as they can be easily retrieved in the case of an audit or FDA inspection.
Source: SWOG Record Retention Guidance; SWOG "List of SWOG Studies with No Required Follow-up" accessible under the "Reports" navigation link on the SWOG CRA Workbench.
- Why are there studies on the List of Protocols with No Required Follow-up that have been closed for years and still do not have a destruction date posted in this report?
Most of these are studies for which either CTEP or SWOG holds the Investigational New Drug (IND) permit. Multiple studies may be added over time to an IND permit so it can remain active for years, until follow-up for all of these studies has ended.
Source: SWOG "List of SWOG Studies with No Required Follow-up" accessible under the "Reports" navigation link on the SWOG CRA Workbench.
- When a study closes to accrual, can we close it out with our IRB if we never enrolled any patients? What about studies with registered patients who all have died or completed their protocol specified follow up period?
It is acceptable to close out any studies that never had any registrations (accrual) to the study.
For all other studies (with registered patients who are off-treatment, no longer being followed or who are deceased), sites may not close the study out with the IRB until the study is added to the List of SWOG Studies with No Required Follow-up.
The "List of SWOG Studies with No Required Follow-up" is available under the "Reports" navigation link on the CRA Workbench and provides a list of studies whose follow-up and data collection have been completed Group-wide.
Even if all queries have been addressed and expectations resolved at the participating site, it is likely the study has not yet completed final analysis and/or the manuscript has not been written. It is common that additional findings will be found where the study team requests clarification of previously submitted data or additional data to ensure data integrity, therefore, new queries may be issued at some future date. It is for this reason that sites must keep the protocol open at their institution until the final analysis is complete. At time of completion of final data analysis (when it is confirmed that no further data clarification will be required), the study will be added to the List of Studies with No Required Follow-Up report on the CRA Workbench.
Source: SWOG "List of SWOG Studies with No Required Follow-up" accessible under the "Reports" navigation link on the SWOG CRA Workbench.
ORP Manual Chapter 10: Long-Term Follow-up (Closing Out Studies for Follow-up section). (Login with CTEP IAM ID required to access link).
- We are closing out the study and we have left over drug, what do we do with it?
If not able to locate relevant drug accountability, transfer, return, or destruction information in the current version of the SWOG protocol (Section 3), then contact:
For CTEP-held IND studies: PMBAfterHours@mail.nih.gov.
For SWOG-held IND studies: Appropriate contact information for the drug distributor will be indicated in the protocol. If unable to locate distributor contract information in the protocol, contact email@example.com.
Source: Current version of respective SWOG protocol (Section 3).
Delegation of Authority
- When does our site need to maintain a site authority log?
A site authority log OR a Delegation of Task Log is required for all clinical trials. Newly activated NCTN trials that involve an investigational agent, require maintenance of an online Delegation of Task Log (per NCI/CTSU site registration requirements) in order to obtain or maintain CTSU-approved status for patient enrollment. See CTSU Resources and Help desk for additional information on maintaining an online DTL (Login with CTEP IAM ID required to access link). For any study that does NOT require an online Delegation of Task Log (maintained via CTSU), SWOG will require a site authority log at time of audit. In lieu of the paper form, SWOG accepts electronic site authority logs (per institutional policy) provided that the log includes the same content as the paper form.
- Can a Nurse Practitioner or other non-physician conduct physical exams or other duties required by protocol?
The registering investigator accepts full responsibility for the treatment and evaluations of patients on research protocols; however, the investigator may delegate some of these duties to a qualified health professional (e.g., nurse practitioner) provided these duties fall within the scope of practice allowed for that locale. A “qualified health professional” is any individual involved in the conduct of the study that is performing functions within the scope of their professional license.
Advanced Practice Providers (APPs) may prescribe/write orders for study agents, including IND agents and standard of care agents, and serve as a local investigator to consent and enroll patients to NCORP protocols funded by NCI DCP and DCCPS.
It is recommended that any individual who makes clinical decisions regarding study subjects be listed as a sub-investigator on the 1572. The duties delegated to these individuals must also be documented on the SWOG Site Authority Log or Delegation of Task Log which must be available for review at the time of an audit.
- SXXXX doesn't have a DTL in the CTSU system, how do I record roles?
For any study that does NOT require an online Delegation of Task Log (maintained via CTSU), SWOG will require a site authority log at time of audit. In lieu of the paper form, SWOG accepts electronic site authority logs (per institutional policy) provided that the log includes the same content as the paper form.
- We have a patient that was just registered to SXXXX who is scheduled to start treatment next week, however I'm not able to login to the PMB Online Agent Ordering Processing Application. Who can order Investigational Agents?
Eligible participating Investigators registered with CTEP, DCTD (or their authorized designee) can order drug via the Online Agent Ordering Processing (OAOP) application.
Access to OAOP requires the establishment of a CTEP Identity and Access Management (IAM) account and the maintenance of an “active” account status and a “current” password. Investigators (or their authorized designee) can request a new OAOP account via a link accessible from the OAOP login page.
Source: CTEP Online Agent Order Processing (OAOP) information webpage;
ORP Manual Chapter 6: Drug Ordering and Maintenance (Login with CTEP IAM ID required to access link).
- Drug administration is not included on the DTL for SXXXX. Can a research nurse administer drug?
Drug administration is not included on the DTL because site procedures may involve drug administration by site staff that are not part of the research team. If there are protocol-specified requirements for administration (such as order of administration, infusion times, vital sign monitoring, etc.), then it is the treating investigator's responsibility to ensure this information is provided to the staff responsible for administration and the protocol procedures are followed. For this reason, and staff that are qualified under local institutional procedures to administer drug may administer the protocol drug(s).
- Do I need to report protocol deviations to SWOG?
Protocol deviations should be reported to the participating institution’s IRB of record, according to the IRB’s policies and procedures. Questions pertaining to whether or not a deviation is reportable to the IRB should be directed to the IRB of record.
- If the CIRB is being utilized as the IRB of record, please note the CIRB guidelines and decision tables for reporting audit findings, unanticipated problems and noncompliance, accessible from: Report A Potential Unanticipated Problem Or A Serious Or Continuing Noncompliance | NCICIRB.
Only those deviations that meet the CIRB’s definition of unanticipated or serious non-compliance should be reported to SWOG. Deviations including a corrective and preventive action plan should be reported to the SWOG Quality Assurance Department via email to: firstname.lastname@example.org.
Source: NCI CIRB Report A Potential Unanticipated Problem Or A Serious Or Continuing Noncompliance.
- The CIRB "Unanticipated Problem and/or Noncompliance Worksheet" asks "Has the Network Group/sponsor, the Study Chair, or a Federal agency been notified of this incident, experience, or outcome? Please answer Yes if information has been reported via Electronic Data Capture (EDC) as part of routine reporting." How do I submit a noncompliance report to SWOG via Electronic Data Capture for SXXXX?
There is an electronic deviation reporting pilot program for S2012. For all other studies, there is no mechanism for reporting protocol deviations. Deviations that meet the CIRB’s definition of unanticipated or serious non-compliance must be reported to SWOG via email to email@example.com. If you reported the deviation to firstname.lastname@example.org, and the deviation report was acknowledged without requiring additional immediate action, then this fulfils the reporting requirement to the Lead Group (SWOG). (There is no further requirement to report via the EDC to SWOG.)
Source: SWOG Quality Assurance FAQs (located under SWOG QA "Additional Resources").
- For SXXXX (a CIRB-only study): Patient 678910 had her blood drawn at 12-month timepoint (last week), however the mandatory biopsy from same timepoint was not performed. How should I proceed re: documentation and reporting?
Failure to collect a mandatory sample (required by protocol) is considered a major deviation and will result in a major deficiency during audit unless the biopsy is scheduled in the near future. If the biopsy will not be performed, please carefully document the reason for not completing the biopsy in the regulatory file. An email to email@example.com is generally sufficient to report the deviation to SWOG. In addition, participating sites should review the CIRB deviation decision information to confirm that the deviation does not warrant reporting to the CIRB.
Source: SWOG Quality Assurance Audit Guidelines (located under SWOG QA "Audit Resources"); NCI CIRB decision algorithms.
- I'm no longer able to locate the COVID-19 minor deviation report form in RAVE for SXXXX. Where is this now located?
Effective June 30, 2022, the NCI removed the requirement to report COVID-19 minor protocol deviations to NCI CIRB at time of Continuing Review (CR) ), and SWOG has removed the associated COVID-19 Diagnosis and Deviation Form from RAVE for most (*) SWOG studies.
* See the SWOG Memorandum link below for SWOG studies that still require reporting of participant’s COVID-19 positive result.
Source: SWOG Memorandum, distributed June 1, 2022.
- My site uses CIRB as the IRB of record, what regulatory documents do I need at time of audit?
Since your site utilizes the CIRB as the IRB of record, only the CIRB Approval of the Study-Specific Worksheet About Local Context documents giving approval to conduct the study as well as documentation of local implementation date for protocol updates and informed consent versions are required for audit. This includes the informed consent document, and any other documents approved by the CIRB for local context use. Note: CIRB protocol approval documents are available on the CTSU website and do NOT need to be printed for/provided to the auditors.
Source: Appendix B: Site Preparation for a SWOG Audit of SWOG Quality Assurance Audit Guidelines (located under SWOG QA "Audit Resources").
- What are the primary reasons participating sites receive an 'unacceptable' score on an audit.
An audit or component of an audit is deemed unacceptable when there are multiple major deficiencies found.
Some examples of common major deficiencies leading to an audit to be found unacceptable are:
* Failure to notify patient of new risks/delayed notification of new risks
* Failure to use most current ICF
* HIPAA document not signed at time of consent
* Enrolled patient not eligible (such as: scans, laboratory assessments, or required baseline eligibility procedures out of window)
* Protocol treatment not given per protocol (such as: failure to administer drug per prescribed protocol dose)
* Failure to modify treatment dose per protocol (such as: failure to dose adjust related to toxicity parameters)
* Failure to perform disease assessments per protocol (such as: failure to perform imaging/scans, procedures, or laboratory assessments per protocol instructions)
* Failure to report Serious Adverse Events (SAEs) or failure to report SAEs within the required timeframe
* Adverse events (AEs) not reported per protocol
* AE laboratory assessments not performed per protocol
* Specimens not submitted per protocol or significantly late submission
* Patient-reported outcome questionnaires not collected per protocol
* Significantly delinquent data (defined as delinquent baseline data submitted >3 months late or other data submitted >6 months late).
Source: Appendix G: Protocol Conduct and Regulatory Documentation Precautions: Common Reasons for an Audit or Component of an Audit to be Deemed Unacceptable (accessible from: ).
- We have an audit upcoming for SXXXX, but I'm not able to find the audit worksheet on CTSU.
Refer to the SWOG Quality Assurance Audit Guidelines and SWOG Site Preparation for an Audit document (which details documentation that auditors will require for review) on the SWOG Quality Assurance & Audits webpage. Note: The auditor will also be contacting you via email in advance of the audit with the request to collate this information for auditor review.
Source: SWOG Quality Assurance Audit Guidelines (located under SWOG QA "Audit Resources") and Site Preparation for a SWOG Audit.
- Can I utilize eSignature if allowed by my local institution?
For patient-facing documents (informed consent, consent addendum, patient facing questionnaires, etc.), SWOG follows NCI CIRB guidance for utilization of eSignatures, as defined in CIRB SOP Section 126.96.36.199.
CIRB SOP Section 188.8.131.52. defines eSignature as an electronic sound, symbol, or process, attached to or logically associated with a contract or other record and executed or adopted by a person with the intent to sign the record.
NCI CIRB guidance indicates that sites are required to submit the information on Study Specific Worksheets (SSW) or the Signatory Institution Worksheet (SIW) worksheets before utilizing eSignatures or electronic consent forms in all circumstances that are not related to the COVID-19 public health emergency.
COVID-19 pandemic-related activity: eSignatures, as defined in CIRB SOP Section 184.108.40.206, are permitted to be implemented for remote consenting during the COVID-19 public health emergency.
For all other research documents (source documents captured via EMR, eligibility checklists/affirmation, etc.), SWOG allows utilization of eSignatures in accordance with institutional procedures.Source: NCI CIRB SOPs, SWOG Policy 19: Quality Assurance Program and SWOG Policy 11: Job Description of a Study Chair, and SWOG Best Practices document (located under SWOG QA "Additional Resources").
- Can we utilize eSignature for remote consent procedures implemented due the COVID-19 pandemic?
eSignatures, as defined in CIRB SOP section 220.127.116.11, are permitted to be implemented immediately for remote consenting during the COVID-19 public health emergency.
Source: NCI CIRB FAQs Regarding COVID-19 and the CIRB and NCI CIRB FAQs Regarding Remote Consent Procedures.