DRC Report Template
For protocols not conducted under internal IND
NOTE TO PI / DESIGNEE: Instructions and examples within this template are provided in blue font. As you complete this report, please delete the instructions/examples, and replace with your data and information.
1.0 Report Date: This is the “end date” of the data in the report; not the date of submission.
2.0 Study H-number:
3.0 Study Title:
4.0 Principal Investigator:
5.0 Brief Study Overview: Include study objectives and treatment schema, if applicable.
6.0 Inclusion / Exclusion Criteria: Current eligibility criteria.
7.0 Study Summary:
7.1 Current Status: Such as: pending; open to accrual; open but closed to accrual; fully closed
7.2 Activation Date: Date the study was fully open to enrollment (may differ from IRB approval date).
7.3 Date of First Enrollment:
7.4 Multi-Site: Yes / No
7.5 Total Target Accrual: the total number of evaluable subjects planned for the study
7.6 Anticipated Accrual Rate (as stated at the time of PRMC review): state as “ X accruals over Y months”
8.0 Principal Investigator Summary Statement
8.1 Study Findings: Summarize study findings to date, including any interim analyses (e.g., toxicities, efficacy, etc.).
8.2 Future Plans: Describe the future plans for the study.
8.3 Correlative Studies: If applicable, provide preliminary results of correlative studies.
9.0 Study Modifications
Summarize any significant protocol amendments or modifications since the last DRC review, and provide the rationale.
Use free text OR complete table below (insert rows as needed).
Amendment / Approval Date / Amendment Summary and RationaleVersion 1.1 / Mo/Day/Year
10.0 Statement of Protocol Conduct: Describe any problems with protocol conduct, such as any issues with subject eligibility, compliance issues, and deviations/variations from the protocol.
11.0 Statistician Summary Statement
Provide a global summary statement, from the study’s assigned statistician.
12.0 Study Enrollments: (If none, can state none)
This is the number of evaluable subjects entered onto the study. Screen failures should not be included. Rows or columns may be added/deleted as needed.
Table 1: Enrollment to Date by InstitutionInstitution / Number of Enrollments
Baylor College of Medicine / 5
Participating Institution A / 1
Participating Institution B / 2
Total (all institutions) / 8
Table 2: Enrollments by Mo/Yr (All Sites)
Month / CY1
(e.g. 2012) / CY2
(e.g. 2013) / CY3
(e.g. 2014) / Total
January / ----- / 3 / 4
February / ----- / 0 / 4
March / ----- / 7 / 0
April / ----- / 0 / 6
May / ----- / 2 / -----
June / ----- / 3 / -----
July / ----- / 8 / -----
August / ----- / 3 / -----
September / ----- / 1 / -----
October / 2 / 8 / -----
November / 1 / 1 / -----
December / 4 / 2 / -----
Total / 7 / 38 / 14 / 59
Table 3: Eligibility and Evaluability
Number
Total Number Enrolled
The number of patients entered into the trial; does not include screen failures. Should equal the “Total” in Tables 1 & 2.
ELIGIBLE: Number of subjects enrolled who were eligible
INELIGIBLE: Number of subjects who, after enrollment, were found to be ineligible. For each one, list immediately below and why they were ineligible.
Ineligible Subject 1: describe reason ineligible
Ineligible Subject 2: describe reason ineligible
Number Evaluable for Response
EVALUABLE: Number of subjects who have completed the study and are evaluable for response.
INEVALUABLE: Number of subjects who did not complete enough of the study to be evaluable for response.
Inevaluable Subject 1: describe reason inevaluable
Inevaluable Subject 2: describe reason inevaluable
TOO EARLY
Number Evaluable for Toxicity
EVALUABLE: Number of subjects who are evaluable for toxicity. (Should include all subjects who received study drug.)
INEVALUABLE: Number of subjects who are inevaluable for toxicity.
Inevaluable Subject 1: describe reason inevaluable
Inevaluable Subject 1: describe reason inevaluable
TOO EARLY
Table 4: Current Patient Status
Current as of [Date]
This table should account for all subjects who are considered enrolled.
Arm
(delete columns that are not needed) / Total
A / B / C
Currently receiving therapy / intervention
Completed protocol therapy / intervention
Removed due to disease progression/relapse
Removed due to adverse event/complication
Removed due to patient withdrawal of consent
Total
Table 5: Subject Characteristics
Add any subject characteristics that are important to the evaluation of the data, such a protocol strata. Irrelevant characteristics can be deleted.
Arm
(delete columns that are not needed)
A / B / C / Total
Gender
Female
Male
Diagnosis (if applicable)
Diagnosis A
Diagnosis B
Stage (if applicable)
I
II
III
Performance Status (if applicable)
0
1
2
3
Total
13.0 Statistical Analysis
13.1 Does the study have stopping rules? If so, please state the stopping rules, and whether or not the study has met these rules.
13.2 Is an interim analysis planned, or has one been done?
13.2.1 Date of Interim Analysis:
13.2.2 Brief description of Interim Analysis results:
14.0 Efficacy Data (if available):
Preferably presented in a table form summarizing the study endpoints.
15.0 Toxicity Data: Complete the table below.
Provide a line listing of all adverse events, organized by disease category or system organ class. Below is an example utilizing CTCAE v4; however, events should be organized in a manner that is compatible with the toxicity schema specified in the protocol. Each event should be a separate line. This table can be submitted as a separate Excel file, if preferred.
System Organ Class / Patient ID / Event / Grade / Study Relationship / Onset DateBlood and lymphatic system disorders / 123 / Anemia / 2 / Probable / 01/01/2013
Blood and lymphatic system disorders / 234 / Hemolysis / 3 / Possible / 02/02/2013
Gastrointestinal disorders / 123 / Abdominal pain / 2 / Possible / 03/01/2013
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