Study Statuses and Subject Accrual
Study Status
• Pre-Open - Study is now going through regulatory review, but has not yet been fully approved and/or has been approved, but is not ready to enroll a subject.
• Open/Enrolling - Study is now ready to enroll a subject. DOES NOT MEAN FULL APPROVAL. DO NOT CHANGE THE STATUS TO OPEN UNTIL THE STUDY IS READY TO BEGIN ENROLLING.
• Re-opened - Study status was Open/Enrolling, moved to Recruitment on Hold, then was allowed to open again to enrollment.
• Closed to Accrual - Study is still open to treatment and other study activity, but no longer enrolling new subjects.
• Closed to Accrual and Intervention - Subjects are no longer being treated or having study-related interventions; subjects may be in follow-up for labs, imaging, completing questionnaires, and other activities.
• Closed- Survival Only - Study is closed to all protocol follow-up activities, however, subjects must be followed for survival status.
• Recruitment on Hold - Study has temporarily closed to enrollment, but there are definitive plans to re-open. This should only be used when a study has been on enrollment hold for greater than 90 days. This will stop the clock on CTSRMC accrual warning activities.
• Withdrawn - Study never opened to enrollment; investigator, sponsor or other entity decided not to move forward with the study.
• Completed - All protocol specific activities are done, ongoing activities are activities like sponsor data collection (not new data), final data query resolutions,or related to IRB or other paperwork. This means the study still has some level of activity requiring the commitment of a Clinical Research Unit/Office’s resources.
• Post-Complete/Finalized - Study activity remains; the study is now fully inactive; study may be archived.
• Terminated - Means that the study prematurely ended
The way the statuses should flow is:
• Pre-open
• Open/Enrolling
• Closed to Accrual
• Closed to Accrual and Intervention
• Closed-Survival Only (for applicable studies)
• Completed
• Post-Complete/Finalized
Subject Accrual and Subject Enrollment
As specified in all CTSRMC approval letters, as you accrue subjects to your studies, you are responsible for registering subjects in Velos/PennCTMS.
Study Statuses to be used for Cancer Center Studies:
• Interested - Participation was discussed with the patient/individual, and they have expressed interest in participating and screening is pending.
• Pre-Consent Screening - Activities related to screening patients/individuals for eligibility which may include signing a screening consent.
• Ineligible - Patient/individual was screened for eligibility and determined to be ineligible; OR Patient/individual was consented with a screening consent and later determined to be ineligible and could not be consented with the main study consent.
• Declined - Participation was discussed with the patient/individual and they declined to participate; OR, Patient/individual was consented with a screening consent then before being consented with the main study consent, decline further participation.
• Consented/Enrolled - The patient/individual was consented with the main study consent and is considered an enrolled study subject.
• Active on Study - After the subject is consented and enrolled, this status indicates the subject is participating in study-related activities.
• On Treatment - This status is specifically to indicate that subjects are receiving a treatment or therapeutic intervention on the study.
• Active Follow-up - The subject is no longer receiving treatment or any type of therapeutic intervention but remains on study for other study required activities.
• Long-term Follow-up - FFor subjects on studies that specifically require subjects to be followed for survival or late AEs.
• Off-treatment/Withdrawn - TThis status should be used when either a) The subject successfully completes all study obligations and participation is complete, or b) The subject is pre-maturely removed from the study which could be the subject's decisions to withdrawal even if this happens immediately following being consented with the main study consent; the PI�s decision to withdrawal the subject; the subject is lost to follow-up; or other reasons as determined by the PI or protocol design. If the subject is withdrawn, a status note must be added to explain the reason.
In order for the ACC to comply with the DHHS, NIH and NCI requirements for reporting enrollment data, and data on Women and Minorities enrolled onto research studies, the following pieces of data are mandated. Missing data will result in the NCI�s system rejecting the subject:
Subject study ID#
Subject First and Last initials
Enrolled date
Gender
Age
Race
Ethnicity (this is a sub-category of race)
Diagnosis
Zip code
For studies that do not collect PHI, use UNK for initials and choose the unknown options in the drop downs.
For subjects who have not yet developed cancer, select �No Cancer� for the diagnosis.
Note: The minimum categories for data on race and ethnicity for Federal statistics, program administrative reporting, and civil rights compliance reporting are defined as follows:
RACES:
• American Indian or Alaska Native: A person having origins in any of the original peoples of North and South America (including Central America), and who maintains tribal affiliation or community attachment.
• Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent, including, for example, Cambodia,China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.
• Black or African American: A person having origins in any of the black racial groups of Africa.
• Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
• White: A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.
Respondents shall be offered the option of selecting one or more racial designations.
ETHNICITY:
• Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term, �Spanish origin,� can be used in addition to �Hispanic or Latino.�
• Non-Hispanic: A person who does not match the definition of Hispanic.
• Unknownd: This category should only be used if a subject refuses to report an ethnicity or due to IRB granted HIPAA waivers that would prevent you from collecting this information. Every attempt should be made to accurately document ethnicity.
Respondents shall be offered the option of selecting one or more racial designations or electing to not identify as a race or ethnicity.
Underperforming Protocols
As mandated by NCI, the CTSRMC must close or require swift corrective actions for protocols that are not making scientific progress which includes accruing subjects. The DOCM runs monthly reports to evaluate the performance of all open protocols. If the accrual data in Velos does not show appropriate accrual, you will receive a letter from the Committee requesting an explanation and plan of action.
NOTE: Your original CTSRMC approval letter details the expectations for subject registration. Failure to comply will result in a study being put on hold or forced to close for non-compliance with the terms of CTSRMC approval.