The Regulatory And Business Roles Of A Study Director

The Regulatory and Business Roles of a Study Director Celeste A. Rose1,* and Donald E. Mayer2 1 2

RoseTECH Consulting, Inc., 1135 Dorothea Drive, Painesville, OH 44077, USA 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 direct responsibility for personnel and other resources required for his/her studies. In this article, we have attempted to identify traits and mechanisms to help the Study Director do his/her job in a professional and compliant manner. In addition to regulatory and scientific expertise, Study Director quality attributes include possession of appropriate soft skills and character traits and are key to the success of a study. Study Directors must have an aptitude for effective communication, relationship building, training, mentoring, and delegation. While these soft skills/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 the study overall. The workshop presented by the authors took a ‘hands-on’ approach building on the creativity, and experience of Study Directors, supervisors, managers, and Quality Assurance (QA) personnel who participated. The participants deliberated problem scenarios from a Study Director’s perspective. The tables and discussion in this article summarize compliant solutions, which arose from the resourcefulness that comes from experience of the participants. Copyright # 2005 John Wiley & Sons, Ltd. Key Words: Study Director; Good Laboratory Practice; GLP; roles and responsibilities; quality attributes; training

Introduction

sibilities and business authority for aspects of the study are not aligned?

In the Good Laboratory Practice (GLP) regulations, the Study Director represents the single point of study control and has overall responsibility 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-

Study Directors generally do not have business control over studies. For example, persons placed in the role of Study Director may or may not have control over personnel management. 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 prioritization 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.

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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, budget, and training, what can a Study Director do to fulfill the obligation to maintain study control?

The Roles/Responsibilities of the Study Director ‘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 compliance.

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, documentation, and reporting of results; and the derivation of study conclusions. In some cases, the individual 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 technique such as advanced mass spectrometry.

Business/administrative role Study Directors undoubtedly have business and administrative job duties, which consume a Copyright r 2005 John Wiley & Sons, Ltd.

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portion of their workday, e.g. supervisory roles or business development responsibilities. Study Directors employed by contract research organizations (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 Environmental 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 quality and integrity are properly noted, and appropriate corrective actions are taken and documented. Raw data, documentation, protocols, specimens, 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 characterization, which is designated in the regulations as management responsibilities, may be delegated either intentionally or by default to the Qual Assur J 2005; 9, 273–282.

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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 compliance issues related to education, experience, and training of personnel; use, maintenance, calibration, and qualification of equipment; validation of computer systems used in the study; existence and applicability of SOPs; record-keeping practices 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 responsibility for multiple concurrently running regulatory studies and many studies today are multisite 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 the Study 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 Copyright r 2005 John Wiley & Sons, Ltd.

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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 compliance 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 Qual Assur J 2005; 9, 273–282.

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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 initiation meetings 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 Investigator organizes the meeting for study personnel 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 topics. These discussions often lead to ‘error prevention’, and result in optimized and updated SOPs, trained personnel, and resource availability. Early identification and correction of study design flaws may reduce occurrence of problems. Study deficiencies or potential problems can be identified and addressed preemptively; often by protocol or protocol amendments or other authorized changes.

Effective communication with study personnel, management, and quality assurance Two-way trust and communication between the Study Director and the study personnel, management, and quality assurance (QA) are fundamental building blocks for successful study Copyright r 2005 John Wiley & Sons, Ltd.

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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 improvement 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 communication between the Study Director and management 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 Economic 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 irresolvable and/or affect study integrity, test site management should consider replacement of the Principal Investigator. Since the study conduct 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 disagreements and conflicts between these individuals Qual Assur J 2005; 9, 273–282.

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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 approach of pre-study meetings may avert disagreements and conflicts by clarifying understandings from the start. The study’s compliance remains the responsibility 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 contribute 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 management 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 Copyright r 2005 John Wiley & Sons, Ltd.

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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 demonstrable competency levels. Given the time pressures around study activities, targeted training makes effective use of personnel and resources. The Study Director, supervisor, and management should confer and determine specific 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 confidence 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. Qual Assur J 2005; 9, 273–282.

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The Study Director should foster an environment 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 importance 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 proceduralized. Delegation should be made with consideration of delegate’s experiences and capabilities. 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 responsibilities and deal with them in an appropriate fashion. For example, in the event that a test article characterization has not been conducted 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 characterization, the analyses require management-provided resources.

Reduction of errors and inefficiencies Errors and inefficiencies can take a manageable situation and turn it into a nightmare. Planning, Copyright r 2005 John Wiley & Sons, Ltd.

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effective communication, training, and mentoring 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 substantial with time. Utilizing under-qualified personnel results in errors and omissions that may remain unnoticed until too late to meaningfully 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 contribute 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 attention 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/updating key SOP(s) prior to use in a study can be effective preventative or corrective measures. A proactive approach, making changes when Qual Assur J 2005; 9, 273–282.

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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 amendment. 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.

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encounter problems outside their direct control or authority. The scenarios were designed to put real life experience and small group creativity to work. The results summarize the workshop scenario and the attendees’ responses for positive/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 independently, 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 frequent.

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

Study Director Workshop Scenario Responses

Practice Standards, 2005. 3. EPA. EPA (TSCA) 40 CFR Part 792, Good Laboratory Practice Standards, 2005.

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

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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 Monitoring Number 8 (Revised). 15 September 1999, ENV/JM/ MONO (99)24.

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Table 1. Scenario No. 1

Table 2. (continued)

What can a Study Director (SD) do when s/he has no control over the personnel assigned to project and there are potential or real (lack of) training issues? Key Phrase: Personnel lack sufficient training for studies assigned. (8 groups responding)

i. Perform risk assessment on critical data. j. Was QA performing in-life inspections? k. Request additional QA inspections and audits. l. Involve supervisor input and training.

Potential solutions (number of groups providing this or comparable response) a. Involve/inform management of needs and actions required. b. Review study needs, decide or prioritize training needs and document appropriately. c. Hold pre-study meeting with assessment of skills inventory of study personnel. d. Review training records to evaluate training needs. e. Use supervisor assistance; supervisors train study personnel prior to study. f. SD needs greater involvement if training is still an issue. g. Review SOPs; review SOPs with employee. h. Notify QA of situation. i. Assign training mentor. j. Involve less trained employees in less critical parts of study. k. Delay study start until employees are trained. l. Daily SD review of data and records.

(1) (1) (1) (1)

Table 3. Scenario No. 3

(3)

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

(2)

Potential solutions (number of groups providing this or comparable response)

(5) (5) (3)

(2) (2) (2) (1) (1) (1) (1)

a. Update SOPs before use in the study. b. Incorporate SOP changes (practices to be used for this study) in the protocol or amendments. c. Document deviations during the study which have already occurred. d. Prepare new SOPs for new concerns or problems encountered during the study. e. SD may approve planned departures/ deviations from SOPs. f. Determine deviation impact on the study.

(5)

(5) (5) (1) (1) (1)

Table 2. Scenario No. 2 What should the Study Director (SD) do when a study is plagued by errors by apparently underqualified personnel during a study? Key Phrase: Errors on study by under-qualified personnel. (5 groups responding) Potential solutions (number of groups providing this or comparable response) a. Assess impact of deviations and problems on study integrity. b. Apprise management. c. Assess training needs of the personnel and train as needed. d. Determine root cause of errors/problems. e. Assure corrective actions and documentation. f. Determine if errors and problems result from poor protocol, study design or SOPs. g. Notify sponsor and/or management if problems severely impact study integrity. h. SD needs to closely monitor study and verify data and training records.

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(4) (4) (3) (3) (3) (3) (2) (2)

Table 4. Scenario No. 4 How as a busy Study Director (SD) do you fulfill your responsibilities in the role of SD and still keep up with day-to-day tasks? These tasks may be other SD’s requests for you to review portions of his/her studies, your assigned SOP reviews/revisions, business development responsibilities, and/or supervisory responsibilities. Key Phrase: Managing time for SD duties and other job functions. (7 groups responding) Potential solutions (number of groups providing this or comparable response) a. Prioritize/time management/scheduling time. b. Delegation of duties to qualified personnel. c. Work long hours. d. Flexibility. e. Multi-tasking. f. Track trends related to study performance issues.

(7) (5) (1) (1) (1) (1)

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Table 4. (continued) g. Quality training. h. Effective communication. i. Management prioritization.

Table 6. (continued) (1) (1) (1)

Table 5. Scenario No. 5 As the Study Director (SD) of several large toxicology animal studies, one of the GLP-mandated functions is to ‘assure that all experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.’ The large amount of data generated in your studies is daunting. Do you delegate some data verification, and if so, how do you decide what to delegate and what do you verify/review yourself? Key Phrase: Delegation of Study Director data review and verification. (6 groups responding) Potential solutions (number of groups providing this or comparable response) a. Review can be delegated (some or all). b. Delegate some data verification to supervisor or to experienced person. c. Reliable QC process needs to be defined. d. ‘Critical’ data remains responsibility of SD to review/verify. e. SOP for SD delegation of data verification is needed. f. QA to review data at regularly scheduled intervals.

(6) (3) (2) (2) (1) (1)

Your management has graciously delegated to you, the Study Director (SD), the responsibility for characterization of test articles and mixtures used in the study. What are the issues, problems, concerns, and solutions? Key Phrase: Management delegated characterization and analysis of test mixtures (to Study Director). (7 groups responding) Potential solutions (number of groups providing this or comparable response)

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d. Develop and validate analytical method inhouse or subcontract/outsource GLP characterization. e. Requirements for testing homogeneity and stability of test mixtures acknowledged. f. Acute toxicology studies frequently are conducted on non-GLP characterized test articles; this is included in compliance statement. g. Rejection of certain studies is likely if nonGLP characterized test article is used. h. Test facility management is responsible to provide analytical capabilities or outsourcing. i. When outsourcing characterization, assure GLP compliance of the subcontractor. j. Include specifics (characterization, analyses, homogeneity, and stability) in protocol.

(3) (3)

(1) (1) (1) (1) (1)

Table 7. Scenario No. 7 You are Study Director (SD) of an OECD multi-site study. Lead QA and your test facility management are at SD site. There are several Principal Investigators (PIs; each with their respective test site management) working on various parts of the study. One of the PIs in not responsive or adequately communicative and important deadlines have slipped or been missed. What can and should you as SD do? Key Phrase: OECD multi-site study, unresponsive Principal Investigator. (6 groups responding) Potential solutions (number of groups providing this or comparable response)

Table 6. Scenario No. 6

a. Determine whether characterization has been performed or not. b. If not characterized under GLP, this becomes a compliance statement item. c. If not GLP characterized, conduct GLP characterization before study.

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(5) (3) (3)

a. SD contact PI and PI management. b. Assess impact of missed deadline as deviation or on study integrity. c. Lead QA reports problems to test facility management, SD, PI, test site management and QA. d. Investigate why PI is unresponsive, determine action to be taken and replace if necessary. e. Contact QA. QA contacts PI and test site QA. f. Was PI site properly qualified to do required work? g. Have procedure in place to deal with situation. h. Lead QA to conduct site visit to assure work performed. i. Communicate situation to sponsor. j. Is test site facility aware of OECD GLP multisite study requirements? k. Has distribution from test facility to test sites included all information, communication, and documents needed to do assigned work?

(4) (4)

(3) (3)

(2) (2) (1) (1) (1) (1)

(1)

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Table 8. Scenario No. 8 You believe you are a conscientious, skilled, thorough Study Director (SD). However, you encounter a QA auditor whose inspections or audit findings and recommendations seem unduly harsh, picky, or unfair. How do you deal with this situation? Key Phrase: Dealing with difficult QA auditor findings. (8 groups responding) Potential solutions (number of groups providing this or comparable response) a. SD and QA person meet to come to common ground. b. Involve supervisor/management for either or both parties. c. Is this an auditor training/skill issue? d. SD is ultimately responsible for the compliance of the study. e. Evaluate the communication in the audit findings. f. Tackle known problems before starting the study; discuss these with QA. g. If SD does not deal with compliance issue, get management support for study quality/integrity/compliance issues.

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(5) (4) (3) (3) (2) (2)

(1)

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