QA Officer Recommended Curriculum Document - v1-0 - FINAL

QA/QC Officer 02QO: Aeras Recommended Curriculum Document
Curriculum Recommendation, Overview [Site renames role title as appropriate]

All QA/QC Officer 02QO
Course Title Availability Course Title Availability
Aeras Principles of Good Clinical
GEN100 Available Q4 2008 GEN201 Aeras Good Documentation Practices Available
Practice (GCP)
GEN101 CID1 Available GEN202 Document Handling and Control TBD
GEN102 E&B1 Available GEN203 Aeras Fundamentals of Instruction Available 2009
GEN103 General Communications TBD GEN204 Project Management Available
GEN104 Group Presentation TBD CLN201 Aeras Informed Consent Process Available
GEN111 CID2 Available CLN202 Aeras Informed Consent Skills Available
GEN112 E&B2 Available
QA/QC Officer 02QO Responsible for

Ensure the Protection of Participant Rights and Safety Oversee Investigator Site File
Ensuring Protection of Participant Rights
CLN217 TBD CLN221 The Investigator Site File TBD
and Safety
Maintain Document Management System Checking Data Processes and Systems for Compliance
Maintaining a Document Management
CLN218 TBD DAT202 Checking Data TBD
System
DAT204 Generating Reports TBD
Manage Deviation Reporting with CAPA Assist with Internal Audit Procedures
CLN219 Managing Deviation Reporting with CAPA TBD CLN222 Internal Audit TBD
Monitor Study Compliance
Course Title Availability
CLN220 Monitoring Study Compliance TBD
Protocol-Related
Protocol-related / SOP Training [Site adds here.]
PRO301 Protocol Training - General Site creates
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Version 1.0 Created by: Aeras Global TB Vaccine Foundation, Professional Development Program
QA/QC Officer 02QO: Duties, Knowledge and Skills List
Purpose To provide a list of the duties & tasks associated with this role and the knowledge and skills necessary to this role.
Duties and Tasks Knowledge Skill

1. Assess and ensure the protection of participant ICH Guidelines Communicate clearly and in a timely manner
rights and safety throughout participation in a • Ethics in clinical research
trial • Adverse drug reaction (ADR) (ICH GCP 1.1) Demonstrate basic computer and Internet skills (MS
1.1. Assist in the development of the • Adverse event (AE) (ICH GCP 1.2) Excel, MS Project and MS Word, or equivalent,
protocol, CRFs and informed consent • Safety Reporting (ICH GCP 4.11) spreadsheets and databases)
documents • Source Documents (ICH GCP 1.52)
1.2. Ensure study staff have adequate
checks in place for complete and Protocol Aptitudes
accurate study documentation • Full understanding of eligibility criteria • Detail-oriented
1.1. Verify informed consent • Understanding of participant study chart
documentation is completed flow through site
before study procedures are
performed Informed Consent
1.2. Verify participants meet • Consent process
eligibility criteria of the study • Required elements of informed consent
and that the investigator has
signed eligibility criteria form Adverse Events
prior to enrollment of • Adverse events that may occur during a
participant study
1.3. Review adverse events
• Sponsor and IRB requirements for adverse
1.1. Verify accurate recording
event reporting
and reporting of any adverse
events that occur
• Basic medical terminology
2. Maintain document management system Study Documents Develop forms and logs
2.1. Coordinate initiation/revision, review • Requirements and guidelines for written Demonstrate basic computer and Internet skills (MS
and approval of controlled study procedures Excel, MS Project and MS Word, or equivalent)
documents • Types of controlled study documents
2.2. Set up system for staff to request • SOP development Aptitudes
creation of or changes to controlled • Process for document control (e.g., tracking • Assertiveness
documents changes, logs to maintain control and • Detail-oriented
2.3. Log controlled study documents access to study documents) • Organized
3.1. Assign numbers to • Requirements for securing and protecting
controlled study documents documents
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3.2. Update and maintain log as • Definition of controlled study document
changes are made to
controlled study documents
2.4. Monitor access to controlled study
documents (i.e., “in/out procedure,
restricted access)
2.5. Maintain all original versions of
controlled documents to track the
history of changes
2.6. Coordinate space for secure and
restricted storage of study documents
and records
3. Collaborate with Professional Development Human Resources and Training Maintain open lines of communication with staff
Program and study management to ensure that • Site training requirements (including set-up
the site has qualified staff by education, training and maintenance of training logs) Demonstrate effective training practices by:
and experience • Regulatory and sponsor requirements for • Explaining procedures
3.1. Ensure training files are complete and employing qualified staff for clinical studies
up-to-date for all study staff
• Facilitating learning
• Hiring process and notifications of new staff
3.2. Assist with tracking completed training • Basic instructional design
• Managing classroom equipment
per established site process (e.g., • Preparing training materials
database, spreadsheet, etc.) • Presenting
3.3. Train study staff on QA/QC processes • Facilitating learning
3.4. Inform Professional Development • Facilitating group discussions
Program and study management on
areas of additional training, retraining
or refresher training for staff based on Demonstrate basic computer and Internet skills (MS
monitoring and auditing activities Excel, MS Project and MS Word, or equivalent,
spreadsheets, databases)
Aptitudes
• Detail-oriented
• Organized
• Managing group dynamics
4. Manage deviation reporting with corrective ICH Guidelines Maintain strong communication with external monitor
action/preventative action (CAPA) • Quality Assurance (ICH GCP 1.46) (sponsor CRA)
4.1. Identify deviations through monitoring • Monitor’s Responsibilities (ICH GCP
activities 5.18.4) Demonstrate basic computer and Internet skills (MS
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4.1.1. Log deviations using • Monitoring Report (ICH GCP 5.18.6) Excel, MS Project and MS Word, or equivalent,
appropriate tool (e.g., • Auditing Procedures (ICH GCP spreadsheets and databases)
database, spreadsheet, etc.) 5.19.3)
4.2. Inform study staff on how and when to • Protocol
report deviations • Deviation reporting requirements of Aptitudes
4.3. Collect and ensure completion of the IRB • Multi-tasking
Protocol Deviation/CAPA Form • Sponsor requirements (in site • Timeliness
4.4. Follow-up on CAPAs contract) • Assertiveness
4.5. Assist PI with compiling and • Teambuilding
disseminating deviation reports to • Managing group dynamics
appropriate parties (e.g., sponsor,
IRB, regulatory authorities)
4.6. Assess trends and conduct
investigations
5. Monitor study compliance with required protocol, ICH Guidelines
written procedures and GCP standards • Quality control in clinical research (ICH Develop written communications
5.1. Check accuracy and completeness of GCP 5.1.3)
CRF entries, source documents and Evaluate adherence to study procedures by:
other trial-related records per Protocol • Observing skills
monitoring plan • Content of CRFs and source documents
5.2. Observe site and study procedures
• Checking for accuracy
• Study procedures required by the • Evaluating performance of staff
per monitoring plan protocol(s)
5.2.1. Conduct spot-checks of
informed consent process in Aptitudes
the field • Detail-oriented
5.2.2. Conduct spot-checks of • Organized
protocol-related procedures
(e.g., follow-up visits,
referrals)
5.2.3. Conduct spot-checks of
other procedures related to
written procedures at the
site
5.3. Document processes and procedures
observed during spot-checks
6. Oversee investigator site file ICH Guidelines
6.1. Check that IRB protocol approvals, all • Independent Ethics Committee (ICH GCP Develop written communications
IRB approved consents and 1.27)
correspondence to ethics committee Aptitudes
• Essential Documents for the Conduct of a
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are present in site file Clinical Trial (ICH GCP 8.1, 8.2, 8.3, 8.4) • Attention to detail
6.2. Check that essential documents for • IRB/EC responsibilities (21 CFR 56) • Organized
investigator site file are in place,
accurate and updated (*essential • Format and content of notes-to-file
documents listed in ICH Guidelines) • IRB procedures and requirements (including
6.3. Work with PI to compile and include all site responsibilities for IRB communication)
required documents in the investigator
site file
6.4. Check that notes-to-file are generated
and in place as necessary
7. Assist with checking data processes and Data/Database Requirements Demonstrate basic computer and Internet skills (MS
systems for compliance • Requirements for compliant data processes Excel, MS Project and MS Word, or equivalent,
7.1. Check that security, controls and and database (FDA 21 CFR Part 11) spreadsheets, databases)
validation procedures are in place for • Data Management Plan
study database • Approval process for changing database Aptitudes
7.2. Ensure changes to study database are • How to document database changes • Detail-oriented
approved and documented • General understanding of how data systems
7.3. Check query process/discrepancy work (including database access)
management to ensure that changes
• Query generation/resolution process
to CRFs or to data entries are
completed and documented as
appropriate
7.4. Review query reports to identify trends
and troubleshoot potential issues and
address CAPAs
8. Assist with internal audit procedures ICH Guidelines Develop written communications
8.1. Identify quality systems at site or, if • Quality Assurance and Quality Control (ICH
applicable, laboratory processes per GCP 5.1) Aptitudes
site audit plan • Observational skills
8.2. Schedule and conduct audits of
• Audit (ICH GCP 5.19)
• Detail-oriented
targeted system or process for • Organized
Protocol
compliance with ICH Guidelines,
Written procedures (e.g., SOPs, plans, manuals)
SOPs and other written procedures
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QA/QC Officer 02QO: Aeras Recommended Curriculum Document

Curriculum Recommendation, Overview [Site renames role title as appropriate]

QA/QC Officer 02QO Responsible for

Duties and Tasks Knowledge Skill

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