Note: You should compare all information entered in this report with what has been previously reported to the IRB. If you discover that there are discrepancies with or errors in previously reported information, please address discrepancies in the summary section. For Chart Review Studies ONLY: Number of records originally estimated for review: Number of records reviewed since last Continuing Review: number of records reviewed since the study began: ***CHART REVIEW STUDIES STOP HERE*** Participant Enrollment: Number of subjects originally estimated for enrollment: Number of screen failures: Number enrolled last Continuing Review: A. Number active receiving study drug or other intervention not performed as part of routine clinical practice (e.g., blood draws, CT scans, MRIs, clinical tests etc.): B. Number active where procedures involve (i) interactions that present no more than minimal risk to subjects (e.g., QOL surveys or phone calls), or (ii) routine clinical practice only: C. Number Completed (no longer in follow-up): D. Number of Voluntary Withdrawals by subject: (List reasons for each withdrawal): E. Number of Investigator/Sponsor-Initiated Withdrawals: (List reasons for each withdrawal): F. Number of consented subjects lost to follow-up: G. Number of subjects deceased: H. Other (Explain): TOTAL Number enrolled since the study began (lines A-H): Investigator’s Signature Date
Note: You should compare all information entered in this report with what has been previously reported to the IRB. If you discover that there are discrepancies with or errors in previously reported information, please address discrepancies in the summary section. For Chart Review Studies ONLY: Number of records originally estimated for review: Number of records reviewed since last Continuing Review: number of records reviewed since the study began: ***CHART REVIEW STUDIES STOP HERE*** Participant Enrollment: Number of subjects originally estimated for enrollment: Number of screen failures: Number enrolled last Continuing Review: A. Number active receiving study drug or other intervention not performed as part of routine clinical practice (e.g., blood draws, CT scans, MRIs, clinical tests etc.): B. Number active where procedures involve (i) interactions that present no more than minimal risk to subjects (e.g., QOL surveys or phone calls), or (ii) routine clinical practice only: C. Number Completed (no longer in follow-up): D. Number of Voluntary Withdrawals by subject: (List reasons for each withdrawal): E. Number of Investigator/Sponsor-Initiated Withdrawals: (List reasons for each withdrawal): F. Number of consented subjects lost to follow-up: G. Number of subjects deceased: H. Other (Explain): TOTAL Number enrolled since the study began (lines A-H): Investigator’s Signature Date