The Regulatory and Business Roles of a Study Director

DOI: 10.1002/qaj.345

The Regulatory and Business Rolesof a Study Director

Celeste A. Rose1,* and Donald E. Mayer2

1 RoseTECH Consulting, Inc., 1135 Dorothea Drive, Painesville, OH 44077, USA2 Don Mayer Quality Consulting, Inc., 11011 Auburn Road, Chardon, OH 44024, USA

Summary

The role of Study Director can be a challenging one with technical, administrative,and compliance responsibilities. The Study Director often does not have directresponsibility for personnel and other resources required for his/her studies. In thisarticle, we have attempted to identify traits and mechanisms to help the StudyDirector do his/her job in a professional and compliant manner.In addition to regulatory and scientific expertise, Study Director quality attributesinclude possession of appropriate soft skills and character traits and are key to thesuccess of a study. Study Directors must have an aptitude for effective communica-tion, relationship building, training, mentoring, and delegation. While these softskills/desirable traits often require additional effort on the part of the Study Director,they have a large impact on the rate of success, efficiency, and compliance of thestudy overall.The workshop presented by the authors took a ‘hands-on’ approach building onthe creativity, and experience of Study Directors, supervisors, managers, andQuality Assurance (QA) personnel who participated. The participants deliberatedproblem scenarios from a Study Director’s perspective. The tables and discussion inthis article summarize compliant solutions, which arose from the resourcefulnessthat comes from experience of the participants. Copyright # 2005 John Wiley &Sons, Ltd.

Key Words: Study Director; Good Laboratory Practice; GLP; roles and responsibilities; qualityattributes; training

Introduction

In the Good Laboratory Practice (GLP) regula-

tions, the Study Director represents the single

point of study control and has overall respon-

sibility for the scientific and technical conduct of

the study [1–4]. What responsibilities are placed

on the Study Director to maintain this control?

What if the Study Director’s regulatory respon-

sibilities and business authority for aspects of

the study are not aligned?

Study Directors generally do not have busi-

ness control over studies. For example, persons

placed in the role of Study Director may

or may not have control over personnel manage-

ment. They may or may not have control

over, or input in, the selection or assignment of

personnel to specific study or project tasks.

Allocation of equipment and other resources are

usually not within Study Director control.

Management generally determines project prior-

itization and expected completion dates.

*Correspondence to: C. A. Rose, RoseTECH Consulting,Inc., 1135 Dorothea Drive, Painesville, OH 44077, USA.E-mail: [email protected]

Copyright r 2005 John Wiley & Sons, Ltd. Qual Assur J 2005; 9, 273–282.

Yet, the Study Director has the regulatory

responsibilities for the control of the study. So, if

a Study Director has limited control over the

assignment of study and support personnel,

resource allocation, prioritization, timing, bud-

get, and training, what can a Study Director

do to fulfill the obligation to maintain study

control?

The Roles/Responsibilities of the StudyDirector

‘Study Director’ is not a typical industry job

title. An individual is rarely hired for the sole

purpose of being a Study Director. Indivi

duals performing the role of Study Director

generally have many other job functions in

addition to the regulatory responsibilities. The

job functions of a Study Director fall into three

categories: technical, administrative, and com-

pliance.

Technical role

The technical role of the Study Director includes

the scientific responsibilities for the study plan/

protocol design and approval; oversight of data

collection, interpretation, analysis, documenta-

tion, and reporting of results; and the derivation

of study conclusions. In some cases, the indivi-

dual may be the lead scientist responsible for the

coordination of the study with other scientists or

Principal Investigators. Persons functioning in

the role of a Study Director may be responsible

for multiple studies. They may also be involved

in non-regulatory projects or regulatory studies

for which they are not Study Directors. For

example, the individual may be the in-house

veterinarian, or a senior scientist who is the

resident expert in a particular analytical techni-

que such as advanced mass spectrometry.

Business/administrative role

Study Directors undoubtedly have business and

administrative job duties, which consume a

portion of their workday, e.g. supervisory roles

or business development responsibilities. Study

Directors employed by contract research orga-

nizations (CRO) have the added obligation of

conducting the study within a profit margin.

Study Directors at sponsor companies have

the business pressure of overseeing that the

study is cost-effective and meets budgetary

constraints.

Compliance role

Thirdly, the Study Director role includes a

number of GLP compliance responsibilities.

Many of these Study Director responsibilities

are clearly stated in the Food and Drug

Administration’s (FDA) 21 Code of Federal

Regulations (CFR) Part 58 and the Environ-

mental Protection Agency (EPA) 40 CFR Parts

160 and 792 GLP regulations [1–3]. The Study

Director has overall responsibility for the

technical conduct of the study, as well as for

the interpretation, analysis, documentation, and

reporting of results and represents the single

point of study control. The Study Director must

also assure that:

* The protocol and any changes are approved

and followed.* Experimental data, including unanticipated

observations, are accurately recorded and

verified.* Circumstances which may affect study qual-

ity and integrity are properly noted, and

appropriate corrective actions are taken and

documented.* Raw data, documentation, protocols, speci-

mens, and final reports are transferred to the

archives.

The GLP regulations state that it is the

responsibility of the Study Director to assure

that all applicable GLP regulations are followed

[1–4]. Some compliance responsibilities are

therefore inherited by the Study Director. For

example, test and control material characteriza-

tion, which is designated in the regulations as

management responsibilities, may be delega-

ted either intentionally or by default to the

274 CA Rose and DE Mayer


Study Director. Training of study personnel may

also fall into the responsibility of the Study

Director.

According to the GLP regulations, the Study

Director is responsible for conduct of the study

and ensuring overall study compliance with the

protocol, standard operating procedures (SOPs),

and the GLP regulations [1–4]. This implies

therefore that in addition to the responsibilities

directly specified in the GLP regulations, the

Study Director is also responsible for compli-

ance issues related to education, experience, and

training of personnel; use, maintenance, calibra-

tion, and qualification of equipment; validation

of computer systems used in the study; existence

and applicability of SOPs; record-keeping prac-

tices and control of study documentation;

handling, storage, and labeling of reagents,

solutions, and mixtures; identification of test

materials and test systems; basically all aspects

of GLP compliance of a study!

Anyone who has ever served in the role of a

Study Director knows that it is indeed a

demanding role. Compounding this burden,

Study Directors frequently have the responsi-

bility for multiple concurrently running regula-

tory studies and many studies today are multi-

site studies as well.

So, how can a Study Director get all this

done? How can a Study Director fulfill all of the

GLP roles and responsibilities as well as the

employer demands and expectations and still do

their job effectively?

Soft Skills and Desirable Traits for theStudy Director

We have all heard the overused adage about

working smarter versus working harder. But

what does that really mean? The obvious come

to mind; skills, training, education, experience.

But all Study Directors have skills, training,

education, and experience (at least they better

according to the GLP regulations!).

In addition to the expected technical skills and

expertise, e.g. animal husbandry, analytical

methodology, equipment operation; other skills

and character traits can make the difference

between a well-executed compliant study and a

study plagued with inherent problems and

compliance issues.

The prototypical Study Director is an effective

communicator with good verbal, written, and

listening communication skills. Relationship

building is also a much-needed skill. It is

through effective communication and strong

relationships that the Study Director can fulfill

regulatory obligations in spite of the lack of

direct business authority.

The Study Director must also be able to

delegate some responsibilities and delegate

wisely. A proficient Study Director determines

which duties are appropriate for delegation and

delegates to study personnel who are competent

in handling the task. An example of such a

responsibility is data verification. On the other

hand, signing of the final report is not a

responsibility that can be delegated in compli-

ance with the GLPs. The ability to recognize

what is important and what is not, and therefore

what can be effectively and safely delegated and

what cannot, is a valuable trait. The skill of

effective delegation is closely related to the

relationship-building characteristic, as trust is a

key part of delegation. Being able to discern

whether or not to trust a delegated task to

someone is very important.

Lastly, the Study Director must be dedicated,

not only to the enormous task of being a Study

Director, but also to the study support team

which has been built to perform and manage the

many facets of a GLP study.

The above traits come about by the same

means with which we acquire all traits; some are

innate, some learned, some developed through

experience and lessons learned. It is important to

be aware of our strengths and weaknesses and

be open to developing and enhancing these

skills, and achieving a balance.

Quality Conduct of Studies

The GLP regulations describe in great detail

the ‘what’ that is required for the execution

The Regulatory and Business Roles of a Study Director 275


of a compliant study. Protocol requirements

(58.120), study conduct requirements (58.130),

final report requirements (58.185), and SOP

requirements (58.81), for example, list what

components must be addressed [1]. Specifics on

requirements for labeling, documentation, test

material handling, and characterization are

detailed in the regulations. But the regulations

do not describe the ‘how’ of executing a quality

study.

The following are proactive and positive

strategies, which can be utilized to achieve study

compliance and quality.

Pre-study planning and study initiationmeetings

Pre-study planning and study initiation meetings

can be an effective approach to heading off

unforeseen or undesirable study issues. These

meetings may be focused on a single study or on

common issues relating to similar types of

studies. The Study Director or Principal Inves-

tigator organizes the meeting for study person-

nel to determine specific needs and issues. Items

such as SOPs and study procedures, personnel

and training, and equipment resources are

examples of pre-study planning discussion to-

pics. These discussions often lead to ‘error

prevention’, and result in optimized and updated

SOPs, trained personnel, and resource availabil-

ity. Early identification and correction of study

design flaws may reduce occurrence of pro-

blems. Study deficiencies or potential problems

can be identified and addressed preemptively;

often by protocol or protocol amendments or

other authorized changes.

Effective communication with studypersonnel, management, and qualityassurance

Two-way trust and communication between the

Study Director and the study personnel, man-

agement, and quality assurance (QA) are funda-

mental building blocks for successful study

conduct. Study personnel who are comfortable

approaching the Study Director will be more

likely to report encountered deviations in a

timely manner. They will also be more likely to

seek assistance when they are unsure of a

situation, or provide suggestions for improve-

ment of procedures or systems. Synergy between

the Study Director and QA with a focus on the

study instead of personalities is a major factor in

study compliance and quality. Effective commu-

nication between the Study Director and man-

agement is vital. For example, the Study

Director must be able to freely discuss with

management the regulatory reasons as well as

business justification for requests for increased

resources whether that be equipment or

personnel. The Study Director must also make

a valiant effort to understand and accept

the business decisions, which may result in

denial of requests.

For multi-site studies, Organization for Eco-

nomic Co-operation and Development (OECD)

GLPs permit the Study Director to delegate

defined responsibility to an individual in the

capacity of a Principal Investigator, although the

Study Director’s responsibility for the overall

conduct of the study cannot be delegated [4–6].

The Study Director and Principal Investigator

must communicate on study issues, including

routine and non-routine matters, deviations, and

problems. In the event of serious communication

difficulties between the Study Director and

Principal Investigator, which become irresolva-

ble and/or affect study integrity, test site

management should consider replacement of

the Principal Investigator. Since the study con-

duct remains the Study Director’s responsibility,

determination of the impact of this action on the

study and appropriate remediation, if required,

needs to occur. Clearly, intercepting problems

like this before they become more serious is

preferential. Full understanding of OECD GLPs

is a necessity.

Communication between QA, Study Director,

Principal Investigator, test site personnel, and

test facility management is necessary to identify

and address study issues. Occasionally disagree-

ments and conflicts between these individuals



and groups do arise. Disagreements and conflicts

may be a result of a misunderstanding or lack of

training. The best resolution involves getting all

parties to a common ground to work out

contentious issues. This often is a difficult task,

in that either or both sides may carry emotional

baggage, which prevents dealing with real

issues. The issues should be focused objectively

on the study rather than subjectively on the

personalities involved. Examination of the

underlying problems may indicate that potential

issues and problems could have been headed off

before the study initiation. The proactive ap-

proach of pre-study meetings may avert dis-

agreements and conflicts by clarifying

understandings from the start.

The study’s compliance remains the responsi-

bility of the Study Director. The Study Director

must decide responsibly how to deal with

QA audit findings, and many other situations.

QA is in a position to help the Study Director

improve the study. QA’s role in documenting

audit findings and recommendations is to con-

tribute to assuring study compliance. Study

Directors should regard QA input from this

perspective.

When all parties have the best interest of the

study in mind, workable solutions are more

easily derived. Involving supervision or manage-

ment of either or both parties may be needed in

some cases. However, their involvement often

comes without a full understanding of the real

issues.

Training and mentoring

Lack of training, under-qualified personnel, and/

or insufficient procedures have a profoundly

negative impact on a study. The Study Director

must usually involve management, employ

resourceful thinking, and seek the help of other

skilled personnel for resolution of matters,

which are outside the Study Director’s direct

control.

Targeted training and skill building of study

personnel are sound approaches for promoting

understanding and assuring that individuals are

capable of performing job functions. Targeted

training is designed to meet specific identified

training needs, aimed at a specific audience.

Training which is effectively targeted and

delivered leads to the achievement of demon-

strable competency levels. Given the time

pressures around study activities, targeted train-

ing makes effective use of personnel and

resources. The Study Director, supervisor, and

management should confer and determine spe-

cific training needs, and provide that training

prior to or during the study.

On-the-job training provided by qualified

skilled personnel is an effective means of

accomplishing this. It is important that trainees

are presented with timely opportunities to utilize

the newly learned skill in order to reinforce the

training. Based on the degree of difficulty of the

newly learned matter or technique, the extent of

direct oversight and follow-up monitoring

needed to ensure adequate demonstration of

competency should be considered.

Mentoring provides the opportunity for less

experienced individuals to gain practical ‘real

life’ occupational knowledge and know-how.

Positive outcomes of mentoring, training,

and skill building of study personnel benefit

the Study Director by establishing confi-

dence to entrust individuals with delegated

tasks.

Delegation of tasks

In order to meet the regulatory responsibilities

and still manage the workload of day-to-day job

functions and tasks, the Study Director must be

an efficient time manager and have the ability to

effectively delegate, multi-task, prioritize, and

schedule time and resources. A Study Director

cannot directly control each and every aspect of

a study; it is only reasonable that some of the

Study Director’s tasks are delegated. Without

some degree of delegation, the Study Director’s

job would be overwhelming and quality of the

study could be negatively affected. Large studies

and even small studies could be arduous and

time consuming.



The Study Director should foster an envir-

onment of cooperation and teamwork to

utilize the delegation option. Good work

habits are required of the Study Director, not

only to do all the tasks, but also to be a

working example to those whose help s/he

utilizes in the delegation of work. The im-

portance of the Study Director’s good work

habits in establishing a team atmosphere and a

level of trust with study personnel cannot be

overstated.

According to GLP the Study Director is

responsible for the accuracy of study data and

its verification or review [1–4]. Delegation of

tasks such as data review and verification to

competent and trusted individuals affords the

Study Director the time for the more critical

study aspects. A reliable process for review

of data should be defined and procedura-

lized. Delegation should be made with consid-

eration of delegate’s experiences and capabil-

ities.

Often, management delegates tasks such as

test article characterization and test mixture

analyses to the Study Director. Study Directors

must be aware of these indirect responsibi-

lities and deal with them in an appropriate

fashion. For example, in the event that a test

article characterization has not been cond-

ucted under GLP or has not been characterized

prior to use in the study, the GLP compliance

statement of the final report must include a

statement of non-compliance (and risk possible

study rejection). When GLP characterization is

required, test facility management must provide

resources for the characterization, whether the

work is done in-house or subcontracted to a

capable GLP lab. Test mixture (homogeneity,

stability, and periodic) analyses are usually

study specific and, like GLP characteri-

zation, the analyses require management-pro-

vided resources.

Reduction of errors and inefficiencies

Errors and inefficiencies can take a manageable

situation and turn it into a nightmare. Planning,

effective communication, training, and mentor-

ing are strategies, which contribute to the

avoidance or minimization of errors. Even a

small error has the potential to critically impact

the integrity of a study. The occurrence of errors,

however, is inevitable. Early detection and

mitigation of errors helps to limit the adverse

effects or impact of the error. The impact of an

error can be exponentially damaging, depending

on the stage at which the error is detected. For

example, a weighing error detected prior to

dosing of an animal causes disruption to the

study but may be easily rectified by documenting

the error and simply re-weighing the animal.

However, if the error goes undetected and the

animal is misdosed, the impact of the error and

the corrective action become increasingly sub-

stantial with time. Utilizing under-qualified

personnel results in errors and omissions that

may remain unnoticed until too late to mean-

ingfully rectify.

Inefficiencies consume personnel resources

and waste valuable time. Under-utilization of

personnel or resources is also wasteful and

may result in employee dissatisfaction and

increased turnover. Imbalance of resources can

result in hasty or inadequate study conduct.

Redundancies can result in over-burdening of

personnel and resources. All of these are

examples of inefficiencies, which could contri-

bute to negative study impacts. The GLP

regulations require a sufficient number of

personnel for the timely and proper conduct of

the study.

Procedural and process improvements

Continuous improvement means diligent atten-

tion to practices used by all study personnel.

SOPs, which are not reflective of current

practices or not suitable for a study, can cause

errors and problems. Revision of procedures and

processes need not, and should not, occur only

at specified review intervals. Reviewing/updat-

ing key SOP(s) prior to use in a study can be

effective preventative or corrective measures.

A proactive approach, making changes when



deficiencies are observed, with appropriate

review and authorized revision, is a working

approach that may prevent many deviations

and/or special change needs. This becomes very

important to the Study Director who must

assure that procedures, SOPs, and methods are

appropriate for each study. When appropriate,

study-specific procedures may be written

directly in the protocol or protocol amend-

ment.

After study initiation, the Study Director

may authorize changes from SOPs, provided

such changes are authorized in advance of

their implementation. Any procedural change,

whether in the form of study documentation

or a formal protocol amendment, must be

communicated to appropriate study personnel.

Unanticipated SOP deviations must always be

documented in the study file and approved

by the Study Director. The Study Director

must assess the impact of problems and

errors encountered during the study. The

issue, including any root cause determination

and corrective action, and study impact

should be documented in the study file.

Errors of severe impact must be brought to

attention of management and sponsor as

appropriate.

Study Director Workshop ScenarioResponses

An interactive workshop, which focused on

Study Director GLP roles and responsibilities

was presented by the authors at the Society

of Quality Assurance Midwest Chapter

(MWSQA) 2005 Spring Meeting in Toledo,

Ohio, USA. The audience was comprised of

about 20% Study Directors, 10% supervisors

and management, and the remaining 70% were

QA persons who were willing to put on the

Study Director’s ‘hat’.

The attendees were presented with scenarios

pertaining to training, SOPs, time management,

people, and other issues for which the Study

Director is responsible by GLP but could

encounter problems outside their direct control

or authority. The scenarios were designed to

put real life experience and small group creati-

vity to work.

The results summarize the workshop sce-

nario and the attendees’ responses for posi-

tive/proactive solutions. The number of groups

responding is indicated in the left-hand

column; frequency of group responses is

indicated in parentheses in the right-hand

column. Because the groups acted indepen-

dently, it should be noted that the numbers of

these summarized responses should not be

expected to add up to total responses. Please

note that the responses listed in Tables 1–8

are not the only correct or possible solutions

but represent what the groups came up with

in a short period of time (ten minutes per

scenario). Other possibilities may exist. The

authors do not endorse these solutions by

frequency of occurrence. Sometimes the most

thoughtful solutions are not the most fre-

quent.

References

1 FDA. FDA 21 CFR Part 58, Good Laboratory Practice for

Nonclinical Laboratory Studies, 2005.

2. EPA. EPA (FIFRA) 40 CFR Part 160, Good Laboratory

Practice Standards, 2005.

3. EPA. EPA (TSCA) 40 CFR Part 792, Good Laboratory

Practice Standards, 2005.

4. OECD. OECD Principles on Good Laboratory Practice,

OECD Series on Principles of Good Laboratory

Practice and Compliance Monitoring Number 1

(as revised in 1997). ENV/MC/CHEM(98)17.

5. OECD. Application of OECD Principles of GLP to the

Organisation and Management of Multi-Site Studies,

OECD Series on Principles of Good Laboratory

Practice and Compliance Monitoring Number 13. 25

June 2002, ENV/JM/MONO (2002)9.

6. OECD. The Role and Responsibility of the Study

Director in GLP Studies, OECD Series on Principles of

Good Laboratory Practice and Compliance Monitor-

ing Number 8 (Revised). 15 September 1999, ENV/JM/

MONO (99)24.



Table 1. Scenario No. 1

What can a Study Director (SD) do when s/he has nocontrol over the personnel assigned to project andthere are potential or real (lack of) training issues?Key Phrase: Personnel lack sufficient training forstudies assigned.(8 groups responding)

Potential solutions (number of groups providing thisor comparable response)

a. Involve/inform management of needs andactions required.

(5)

b. Review study needs, decide or prioritizetraining needs and document appropriately.

(5)

c. Hold pre-study meeting with assessment ofskills inventory of study personnel.

(3)

d. Review training records to evaluate trainingneeds.

(3)

e. Use supervisor assistance; supervisors trainstudy personnel prior to study.

(2)

f. SD needs greater involvement if training isstill an issue.

(2)

g. Review SOPs; review SOPs with employee. (2)h. Notify QA of situation. (2)i. Assign training mentor. (1)j. Involve less trained employees in less criticalparts of study.

(1)

k. Delay study start until employees aretrained.

(1)

l. Daily SD review of data and records. (1)


What should the Study Director (SD) do when astudy is plagued by errors by apparently under-qualified personnel during a study?Key Phrase: Errors on study by under-qualifiedpersonnel.(5 groups responding)


a. Assess impact of deviations and problems onstudy integrity.

(4)

b. Apprise management. (4)c. Assess training needs of the personnel andtrain as needed.

(3)

d. Determine root cause of errors/problems. (3)e. Assure corrective actions anddocumentation.

(3)

f. Determine if errors and problems result frompoor protocol, study design or SOPs.

(3)

g. Notify sponsor and/or management ifproblems severely impact study integrity.

(2)

h. SD needs to closely monitor study and verifydata and training records.

(2)

i. Perform risk assessment on critical data. (1)j. Was QA performing in-life inspections? (1)k. Request additional QA inspections andaudits.

(1)

l. Involve supervisor input and training. (1)


How as a busy Study Director (SD) do you fulfillyour responsibilities in the role of SD andstill keep up with day-to-day tasks? These tasksmay be other SD’s requests for you to reviewportions of his/her studies, your assigned SOPreviews/revisions, business development responsi-bilities, and/or supervisory responsibilities.Key Phrase: Managing time for SD duties and otherjob functions.(7 groups responding)


a. Prioritize/time management/schedulingtime.

(7)

b. Delegation of duties to qualified personnel. (5)c. Work long hours. (1)d. Flexibility. (1)e. Multi-tasking. (1)f. Track trends related to study performanceissues.

(1)


As Study Director (SD), you are responsible for studyconduct, including following SOPs. You observe thatsome of the SOPs for your studies are not reflectiveof current practice or are deficient in a number ofpossible ways. What do you do?Key Phrase: SOPs not reflective of current practice.(7 groups responding)


a. Update SOPs before use in the study. (5)b. Incorporate SOP changes (practices to beused for this study)in the protocol or amendments. (5)c. Document deviations during the studywhich have already occurred.

(5)

d. Prepare new SOPs for new concerns orproblems encountered during the study.

(1)

e. SD may approve planned departures/deviations from SOPs.

(1)

f. Determine deviation impact on the study. (1)

Table 2. (continued)




As the Study Director (SD) of several large toxicologyanimal studies, one of the GLP-mandated functionsis to ‘assure that all experimental data, includingobservations of unanticipated responses of the testsystem are accurately recorded and verified.’ Thelarge amount of data generated in your studies isdaunting. Do you delegate some data verification,and if so, how do you decide what to delegate andwhat do you verify/review yourself?Key Phrase: Delegation of Study Director datareview and verification.(6 groups responding)


a. Review can be delegated (some or all). (6)b. Delegate some data verification tosupervisor or to experienced person.

(3)

c. Reliable QC process needs to be defined. (2)d. ‘Critical’ data remains responsibility of SD toreview/verify.

(2)

e. SOP for SD delegation of data verification isneeded.

(1)

f. QA to review data at regularly scheduledintervals.

(1)


Your management has graciously delegated toyou, the Study Director (SD), the responsibilityfor characterization of test articles and mixturesused in the study. What are the issues, problems,concerns, and solutions?Key Phrase: Management delegatedcharacterization and analysis of test mixtures (toStudy Director).(7 groups responding)


a. Determine whether characterization hasbeen performed or not.

(5)

b. If not characterized under GLP, this becomesa compliance statement item.

(3)

c. If not GLP characterized, conduct GLPcharacterization before study.

(3)

d. Develop and validate analytical method in-house or subcontract/outsourceGLP characterization. (3)e. Requirements for testing homogeneity andstability of test mixtures acknowledged.

(3)

f. Acute toxicology studies frequently areconducted on non-GLP characterized testarticles;this is included in compliance statement. (1)g. Rejection of certain studies is likely if non-GLP characterized test article is used.

(1)

h. Test facility management is responsible toprovide analytical capabilities or outsourcing.

(1)

i. When outsourcing characterization, assureGLP compliance of the subcontractor.

(1)

j. Include specifics (characterization, analyses,homogeneity, and stability) in protocol.

(1)


You are Study Director (SD) of an OECD multi-sitestudy. Lead QA and your test facility management areat SD site. There are several Principal Inves-tigators (PIs; each with their respective test sitemanagement) working on various parts of the study.One of the PIs in not responsive or adequatelycommunicative and important deadlines have slippedor been missed. What can and should you as SD do?Key Phrase: OECD multi-site study, unresponsivePrincipal Investigator.(6 groups responding)


a. SD contact PI and PI management. (4)b. Assess impact of missed deadline asdeviation or on study integrity.

(4)

c. Lead QA reports problems to test facilitymanagement, SD, PI, test site managementand QA. (3)d. Investigate why PI is unresponsive,determine action to be taken and replace ifnecessary.

(3)

e. Contact QA. QA contacts PI and test site QA. (2)f. Was PI site properly qualified to do requiredwork?

(2)

g. Have procedure in place to deal with situation. (1)h. Lead QA to conduct site visit to assure workperformed.

(1)

i. Communicate situation to sponsor. (1)j. Is test site facility aware of OECD GLP multi-site study requirements?

(1)

k. Has distribution from test facility to test sitesincluded all information, communication,and documents needed to do assigned work? (1)

g. Quality training. (1)h. Effective communication. (1)i. Management prioritization. (1)

Table 4. (continued) Table 6. (continued)




You believe you are a conscientious, skilled,thorough Study Director (SD). However, youencounter a QA auditor whose inspections oraudit findings and recommendations seem undulyharsh, picky, or unfair. How do you deal withthis situation?Key Phrase: Dealing with difficult QA auditorfindings.(8 groups responding)


a. SD and QA person meet to come to commonground.

(5)

b. Involve supervisor/management for eitheror both parties.

(4)

c. Is this an auditor training/skill issue? (3)d. SD is ultimately responsible for thecompliance of the study.

(3)

e. Evaluate the communication in the auditfindings.

(2)

f. Tackle known problems before starting thestudy; discuss these with QA.

(2)

g. If SD does not deal with compliance issue,get management support for studyquality/integrity/compliance issues. (1)



Documents

The Regulatory and Business Roles of a Study Director