IRB Performance Evaluation Scoring Template
Protocol Analyst I
Key Function
1.
Prepares and processes
new research proposals,
amendments, and continuing
review applications
preceding IRB Committee
meetings, according to
institutional/departmental
policy and federal
regulations.
Weighting
Score 1 - Does not perform
20%
Rarely performs pre-review of all
IRB documents, utilizing the
appropriate IRB checklist.
Rarely verifies all required fields
on the application are complete
and all required documents are
attached. Rarely reviews and
verifies the informed consent
document for inclusion of
required eight elements and
understandability for target
population.
Rarely creates agenda
according to IRB policies and
procedures. Rarely completes
packets that reflect an accurate
agenda template.
Rarely completes review and
letters for expedited
submissions according to target
goals as stated in the IRB
measures of success.
Rarely sends Continuing Review
Notices at 8, 4 and 2 weeks.
Rarely strives to prevent lapse
beyond expiration date.
2. Documents IRB Committee
Meetings according to IRB Policies
January 2004
10%
Rarely responds appropriately to
general IRB questions from
Committee Members, Principal
Investigators, and Staff. Rarely
seeks leadership assistance in
handling conflict or responding
to general IRB questions.
Rarely exhibits basic knowledge
of IRB policies and procedures
Score 3 - Competent to
Perform
With supervision, performs
thorough pre-review of all IRB
documents, utilizing the
appropriate IRB checklists.
Consistently verifies all
required fields on the
application are complete and
all required documents are
attached. Consistently reviews
and verifies the informed
consent document for inclusion
of required eight elements and
understandability for target
population.
Consistently creates complete
packets that reflect an accurate
agenda template.
With supervision, completes
thorough review and letters for
expedited submissions
according to target goals as
stated in the IRB measures of
success.
Score 5 - Expert Performance
Consistently exceeds target goals
as stated in the IRB measures of
success for key function #1 tasks.
Consistently analyzes and seeks
ways to improve processes
associated with key function #1
tasks.
Takes initiative and accepts
responsibility for sending
Continuing Review notifications
and follows up to prevent lapse
beyond the expiration date.
Accepts responsibility for
responding to general IRB
questions. Readily seeks
assistance/ guidance as
appropriate.
Completes Continuing Review
notifications at 8, 4, and 2
weeks. Diligently strives to
prevent lapse beyond
expiration date.
Consistently accepts
responsibility for responding to
general IRB questions.
Readily seeks assistance/
guidance as appropriate.
Consistently demonstrates
basic knowledge of IRB
Evaluates current meeting process
and develops sound ideas to
IRB Performance Evaluation Scoring Template
Protocol Analyst I
Key Function
Weighting
and Procedures.
3. Processing and follow up of new
research proposals, amendments,
continuing review applications and
adverse events succeeding IRB
Committee Meetings according to
IRB Policies and Procedures.
January 2004
Score 1 - Does not perform
and federal regulations relating
to IRB committee process.
20%
Score 3 - Competent to
Perform
policies and procedures and
federal regulations relating to
IRB committee process.
Rarely ensures Committee
meeting materials are ready for
the Committee, including motion
prompters, reviewer sheets,
name tags, files, and any
catering needs.
Consistently ensures that all
required meeting essentials
are available and organized
prior to start time.
Rarely documents accurate
discussion, motions, notes and
attendance according to federal
regulations.
Accurately captures and
documents the content of the
committee discussion, motions,
votes and attendance
according to federal
regulations.
Rarely participates in the round
table discussion immediately
following the IRB committee
meeting to verify the accurate
capture of committee discussion
and decisions.
Actively participates in a
convened meeting (round
table) immediately following
IRB committee meetings to
verify the accurate capture of
committee discussion and
decisions.
Rarely creates minutes template
and distributes round table
comments to committee
members within the stated
target goals of the IRB
Measures of Success.
Distributes round table
comments to committee
members within the stated
target goals of the IRB
Measures of Success.
Rarely develops quality
documents free of typographical
errors, using good punctuation
and grammar. Rarely writes
concise, accurate, organized,
and customer friendly
documents.
Develops quality documents
free of typographical errors,
using good punctuation and
grammar. Writes concise,
accurate, organized and
customer friendly documents
with supervision.
Score 5 - Expert Performance
improve the quality and cost
effectiveness of the meetings.
Demonstrates basic facilitative
leadership skills.
Evaluates and suggests
improvements to the round table
process, including facilitating
discussion. Is flexible, open and
encourages other's input.
Evaluates or analyzes quality of
documents. Seeks ways to
improve quality of documents.
Consistently exceeds target goals
as stated in the IRB measures of
success for key function #3 tasks
IRB Performance Evaluation Scoring Template
Protocol Analyst I
Key Function
4. Ensure the integrity and security
of IRB data, whether in paper or
electronic format.
5. Actively identifies and participates
in training, education and
development activities to improve
own knowledge and performance to
sustain and enhance own
professional development.
January 2004
Weighting
Score 1 - Does not perform
15%
Rarely enters data promptly and
accurately into the IRB database
ensuring all data fields are
completed according to IRB
policies and procedures.
5%
Rarely organizes and collates
files accurately according to IRB
policies and procedures.
Score 3 - Competent to
Perform
Promptly and accurately enters
data into the IRB database
according to IRB policies and
procedures. Verifies the
accuracy of existing data by
promptly updating the
database or file when
inconsistencies, inaccuracies,
or omissions are identified.
Rarely adheres to institutional
and departmental confidentiality
and security policies and
procedures.
Consistently organizes and
collates files accurately
according to IRB policies and
procedures.
Does not utilize the Belmont
Report, OHRP regulations
including subparts A, B, C, & D,
and the FDA regulations
specifically related to drugs and
devices as a resource.
Adheres to institutional and
departmental confidentiality
and security policies and
procedures. Signs
confidentiality statement
annually.
Consistently utilizes the
Belmont Report, OHRP
regulations including subparts
A, B, C, & D, and the FDA
regulations specifically related
to drugs and devices as a
resource.
Score 5 - Expert Performance
Troubleshoots data issues and
identifies methods to improve the
integrity of the data.
Challenges peers to protect the
accuracy and consistency of the
data within the files and the
database.
Accurately applies and interprets
the principles outlined in the
Belmont Report, and the OHRP
regulations including subparts A,
B, C, & D, and the FDA regulations
specifically related to drugs and
devices as a resource.
Rarely identifies and participates
in training, education and
development activities. Does
not take responsibility for
scheduling and attending
assigned professional
development activities.
Participates in training,
education and development
activities. Takes responsibility
for scheduling and attending
assigned professional
development activities.
Attends educational opportunities
as directed and willingly shares
new information with peers.
Discusses application of new
knowledge with team.
Does not attend one formal
regional/national conference or
training per year and does not
engage in 4 informal educational
Attends one formal
regional/national conference or
training per year and engages
in 4 informal educational
Engages in 12 informal
educational opportunities per year.
Documents professional
development activities for
IRB Performance Evaluation Scoring Template
Protocol Analyst I
Key Function
Weighting
Score 1 - Does not perform
opportunities a year. Fails to
document training participation
for evaluation process.
Rarely demonstrates a
willingness to learn new skills
and adapt to an ever-changing
environment.
Rarely demonstrates a positive
attitude in response to
suggestions for improvement.
6. Demonstrates awareness of
continuous quality improvement
(CQI) tools and methods in daily
work activities.
5%
Rarely takes responsibility for
seeking a solution to any
problem or complaint from our
customers and department.
Does not effectively
communicate resolution to
customer, staff, and
management.
Rarely seeks ways to improve
daily processes and procedures.
Rarely participates in data
collection activities and rarely
conducts CQI and basic audits
according to specific
instructions.
Rarely respects cost-effective
measures with respect to time
and money.
January 2004
Score 3 - Competent to
Perform
opportunities a year.
Documents all training
participation for evaluation
process.
Demonstrates a willingness to
learn new skills and adapt to
an ever-changing environment
and accepts constructive
criticism.
Score 5 - Expert Performance
evaluation process.
Consistently demonstrates a
positive attitude in response to
suggestions for improvement and
proactively seeks out growth
opportunities in identified areas of
weakness.
Routinely demonstrates a
positive attitude in response to
suggestions for improvement
and participates in
development opportunities in
identified areas of weakness.
Takes responsibility for finding
solutions to any problems or
complaints from our customers
and department. Identifies
when problem requires
escalation for resolution.
Effectively communicates
resolution to customer, staff,
and management.
Anticipates problems and
discusses with team to create an
action plan.
Actively seeks ways to improve
daily processes and
procedures.
Understands basic concepts of
CQI process and actively
participates in the design and
completion of the PDCA cycle.
Actively participates in data
collection activities and rarely
conducts CQI and basic audits
according to specific
instructions.
Respects cost-effective
Continuously evaluates processes,
identifying trends and solutions
and implementing action in
collaboration with our customers to
meet current and future goals.
IRB Performance Evaluation Scoring Template
Protocol Analyst I
Key Function
7. Demonstrates characteristics of
an effective team member.
Weighting
15%
Score 1 - Does not perform
Rarely understands, supports,
and commits to team and
departmental goals. Rarely
exerts extra effort when
necessary to accomplish team
and departmental goals.
Does not respect all team
members as unique individuals
with valuable input and skills
that enhance the team. Rarely
interacts with team members
and departmental staff in a
constructive manner.
Rarely demonstrates a positive
attitude in response to
suggestions for professional and
departmental improvements,
including participation in
institutional/departmental team
building class.
Rarely recognizes areas of
responsibility and takes charge
of them, including taking
responsibility for mistakes and
learns from them.
January 2004
Score 3 - Competent to
Perform
measures with respect to time
and money.
Understands, supports and
demonstrates ownership for
team’s goals. Recognizes
areas of responsibility and
demonstrates a willingness to
shift roles to accomplish the
team’s goals.
Respects all team members as
unique individuals with
valuable input and skills that
enhance the team.
Demonstrates a positive
attitude in response to
suggestions for professional
and departmental
improvements.
Score 5 - Expert Performance
Consistently places the
needs/goals of the team and
department as a priority.
Frequently evaluates the
effectiveness of the team and
constantly strives to meet
departmental and institutional
goals.
Actively re-directs negative,
unsupportive conversation to
achieve a constructive, positive
outcome.
Continuously elicits feedback from
team members and customers to
improve team’s performance.