Form 1 Attachment 1 DAIDS cQMP

Clinical Research Site (CRS)

Quality Assurance (QA) Summary Report

Site Name
Role of Person Preparing Report

Period of Review: (Date)

_

OMB Control #: 0925-0668
Expiration Date: 1/31/2016

Site Number
Date of QA Report

to (Date) ___________________

1. Composition of PIDs reviewed;
a. Number of newly enrolled PIDs at CRS during this period (=m)
b. Number of new PIDs reviewed (=n) ______________
c. Total number of PIDs reviewed (old PIDs +Newly enrolled PIDs=x) ____________
d. Total enrollment at CRS (y) ______________
e. Percent of newly enrolled PIDs reviewed (=n/m *100) _______________
f. Percent of total PIDs reviewed (=x/y *100) ______________
(Please remember to increase percent reviewed based on newly enrolling protocols, complex protocols, records completed by new staff, etc.)

Burden Disclosure: Public reporting burden for this collection of information is estimated to average 15 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An
agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control
number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to:
NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA# 0925-0668. Do not return the completed form to
this address.

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Clinical Research Site (CRS)
Quality Assurance (QA) Summary Report
2. Summary of protocols reviewed
Note: Complete only for protocols of PIDs reviewed for chart Review. All cells may not need to be completed
Protocol

First participant enrolled (yr)

Number of records reviewed

3. List Quality Control (QC)/Quality Assurance Tools used for this review

2

OMB Control #: 0925-0668
Expiration Date: 1/31/2016

Clinical Research Site (CRS)
Quality Assurance (QA) Summary Report
4. Summary of key quality indicators and number of findings
Indicators

3

Number of findings

OMB Control #: 0925-0668
Expiration Date: 1/31/2016

Clinical Research Site (CRS)
Quality Assurance (QA) Summary Report

OMB Control #: 0925-0668
Expiration Date: 1/31/2016

5. Summary of deficient key indicator and criteria(s)
PID #

4

Protocol #

Deficient key
indicator(s)
identified

List the criteria identified
for corresponding indicator

Corrective action implemented? Describe

Is corrective
action
effective?

Clinical Research Site (CRS)

Quality Assurance (QA) Summary Report

PID #

5

Protocol #

Deficient key
indicator(s)
identified

List the criteria identified
for corresponding indicator

OMB Control #: 0925-0668
Expiration Date: 1/31/2016

Corrective action implemented? Describe

Is corrective
action
effective?

Clinical Research Site (CRS)

Quality Assurance (QA) Summary Report

PID #

6

Protocol #

Deficient key
indicator(s)
identified

OMB Control #: 0925-0668
Expiration Date: 1/31/2016

List the criteria identified
Corrective action implemented? Describe
for corresponding indicator

Is corrective
action
effective?

Clinical Research Site (CRS)
Quality Assurance (QA) Summary Report

OMB Control #: 0925-0668
Expiration Date: 1/31/2016

Regulatory File Review
Based on findings identified in the Quarterly Clinical Quality Management Regulatory File Review Tool, complete the following questions

1. Was a Quality Assurance review of the Regulatory File conducted during this quarter?

Y______ N_____

2. If no, provide an explanation

3. If yes, specify associated protocol and complete table below per protocol(s) reviewed
Protocol reviewed

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Identified issues (list and
describe)

Corrective action(s) implemented, per issue
identified

Comments

Protocol reviewed

Clinical Research Site (CRS)

Quality Assurance (QA) Summary Report

Identified issues (list and
describe)

Corrective action(s) implemented, per issue
identified

OMB Control #: 0925-0668
Expiration Date: 1/31/2016

Comments

4. Clinical Quality Management Plan (CQMP) Revision
a. Does the CQMP need revision based on the findings of this Quality Assurance audit? Y______ N _____
b. If yes, please specify areas to be revised

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