QUALITY PRACTICES

(1)

TRAINING MANUAL

Q ^uality ^practices

in basic biomedical research (Qpbr)

TRAINEE

Special Programme for Research & Training in Tropical Diseases (TDR) sponsored by

U N I C E F / U N D P / W o r l d B a n k / W H O

Special Programme for Research & Training in Tropical Diseases (TDR) sponsored by U N I C E F / U N D P / W o r l d B a n k / W H O

(2)

1.Biomedical research - methods. 2.Quality control. 3.Ethics, Research. 4.Manuals. 5.Teaching materials. I.UNDP/

World Bank/WHO Special Programme for Research and Training in Tropical Diseases.

ISBN 978 92 4 159921 4 (NLM classification: W 20.5)

The use of content from this health information product for all non-commercial education, training and information purpos- es is encouraged, including translation, quotation and reproduction, in any medium, but the content must not be changed and full acknowledgement of the source must be clearly stated. A copy of any resulting product with such content should be sent to TDR, World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland. TDR is a World Health Organization (WHO) executed UNICEF/UNDP/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases.

The use of any information or content whatsoever from it for publicity or advertising, or for any commercial or income-gen- erating purpose, is strictly prohibited. No elements of this information product, in part or in whole, may be used to promote any speciﬁc individual, entity or product, in any manner whatsoever.

The designations employed and the presentation of material in this health information product, including maps and other illustrative materials, do not imply the expression of any opinion whatsoever on the part of WHO, including TDR, the authors or any parties cooperating in the production, concerning the legal status of any country, territory, city or area, or of its authorities, or concerning the delineation of frontiers and borders.

Mention or depiction of any speciﬁc product or commercial enterprise does not imply endorsement or recommendation by WHO, including TDR, the authors or any parties cooperating in the production, in preference to others of a similar nature not mentioned or

depicted.

The views expressed in this health information product are those of the authors and do not necessarily reﬂect those of WHO, including TDR. WHO, including TDR, and the authors of this health information product make no warranties or representa- tions regarding the content, presentation, appearance, completeness or accuracy in any medium and shall not be held liable for any damages whatsoever as a result of its use or application. WHO, including TDR, reserves the right to make updates and changes without notice and accepts no liability for any errors or omissions in this regard. Any alteration to the original content brought about by display or access through different media is not the responsibility of WHO, including TDR, or the authors. WHO, including TDR, and the authors accept no responsibility whatsoever for any inaccurate advice or information that is provided by sources reached via linkages or references to this health information product.

Design: Lisa Schwarb Layout: Sabine de Jonckheere

(3)

QUALITY PRACTICES

IN BASIC BIOMEDICAL RESEARCH (QPBR) TRAINING MANUAL

FOR THE TRAINEE

A tool for training and promoting

Quality Practices in Basic Biomedical Research (QPBR)

concepts in disease endemic countries

(4)

ii

FOREWORD...1

ABOUT THIS TRAINING MANUAL ...2

ACKNOWLEDGEMENTS ...4

INTRODUCTION ...5

SESSION 1 ...8

1.1 QUALITY PRACTICES IN BASIC BIOMEDICAL RESEARCH ...8

1.2 WHAT IS QUALITY IN RESEARCH ? ...19

SESSION 2 ...31

2.1 ORGANIZATION ...31

2.2 PHYSICAL RESOURCES ...39

SESSION 3 ...50

3.1 DOCUMENTATION – OVERVIEW ...50

3.2 DOCUMENTATION – PRESCRIPTIVE DOCUMENTATION ...58

3.3 DOCUMENTATION – DESCRIPTIVE DOCUMENTATION: RAW DATA AND RECORDS ...64

3.4 DOCUMENTATION – REPORTS AND STORAGE ...75

(5)

iii

SESSION 4 ...84

4.1 SUPERVISION AND QUALITY ASSURANCE ...84

4.2 PUBLISHING PRACTICES ...94

4.3 ETHICAL CONSIDERATIONS ...104

SESSION 5 ...114

5.1 CASE STUDIES ...114

5.1.1 TEST ITEM IN ANIMAL MODEL ...114

5.1.2 RESULTS NOT TO BE REPORTED ...114

5.1.3 UNREPORTED VALUES ...115

5.1.4 TECHNOLOGY TRANSFER ...115

5.1.5 BLOOD SAMPLE LOGISTICS AND HANDLING ...115

5.1.6 MULTISITE MULTI-HEADACHES ...115

5.1.7 SCIENTIFIC PEER REVIEW ...116

5.1.8 PREPARING A POLICY DOCUMENT ...116

5.1.9 INVESTIGATING THE UNEXPECTED ...116

5.1.10 IMPLEMENTATION CASE STUDY ...117

SESSION 6 ...118

6.1 WRAP-UP AND EVALUATION ...118

6.2 ISSUING OF CERTIFICATE AND CLOSURE ...118

(6)

(7)

1

FOREWORD

A key aim of the Special Programme for Research and Training in Tropical Diseases (TDR) is to empower disease endemic countries (DECs) to develop and lead high quality research activities to internationally recognized standards of quality, and so contribute to TDR’s primary mission of “fostering an effective global research effort on infectious diseases of poverty in which disease endemic countries pay a pivotal role”.

One way we have approached this is to produce guidelines and training manuals that will help institutions and researchers attain the highest international quality standards in their research. In 2006 we published a handbook on Quality Practices in Basic Biomedical Research (QPBR) which received worldwide acceptance and acclaim, from both industry and academia. It also created a demand for training, especially in DECs.

This manual (for trainees), and the accompanying manual (for trainers) will help meet this demand, and will assist institutions in implementing good quality practices. The two manuals, together with the QPBR handbook, now form a sister series to the highly pop- ular series on Good Laboratory Practice (GLP), which has had an impact on the way that laboratory research is carried out in many institutions and countries.

We anticipate that this manual will be useful to all those who aspire to undertaking biomedical research to the best international standards. We believe it will be particularly useful when used with the trainers’ manual in workshops and courses on good quality practices. Used together, the QPBR series will help institutions and researchers ensure that research work is produced, recorded, reported and archived appropriately and in a cost- effective and efficient manner.

Dr Robert Ridley, Director TDR, Special Programme for Research and Training in Tropical Diseases Executed by WHO and co-sponsored by UNICEF, UNDP, the World Bank and WHO

(8)

2

Quality practices in basic biomedical research are of paramount importance when resources are limited and when the results of research are to be used to advance science, shape policies or aid decision making. This applies particularly to disease endemic countries (DECs), although quality practices in research are just as essential for other parts of the world.

Establishing good quality practices in research can only improve the quality of research and the veracity of data derived from it. Guidelines on quality of research also steer researchers towards approaching their work in a similar way, no matter where they are working. This is a critical element in research, allowing experiments to be reproduced more easily and the body of evidence on a particular research issue to grow.

In the absence of national or international guidelines on Quality Practices in Basic Medical Research, in 2006 TDR published at WHO a Handbook on Quality Practices in Basic Biomedical Research (QBPR) to help researchers throughout the world produce high-quality biomedical research. The handbook highlighted non-regulatory practices that can be easily institutionalized at very little extra expense.

The QPBR handbook was so well received and the demand for training so high (especially in DECs) that the decision was made to develop this brand new manual for trainees of QPBR and an accompanying manual for trainers.

The two QPBR training manuals are based on the QPBR handbook and are designed around a course / workshop on QPBR. They therefore outline the goals of the course / workshop and the topics that should be covered. The manuals include a set of power point slides, questions and case histories on QPBR. The QPBR handbook explains why QPBR is essential and also provides help (through illustrative examples and templates) on how QPBR can be implemented.

(9)

3

The training manuals can be used to conduct standardized and validated training; they provide institutions and researchers with the necessary tools for implementing and moni- toring quality practices in their research. Training of trainers will lead to propagation of the number of individuals who can train others about QPBR.

The QPBR series supports TDR’s long-term mission of helping DECs develop their own research activities. Training efforts throughout the world, especially in Asia, Latin America and Africa, will lead to the formation of a global culture of quality practice in research. This in turn should help institutions in their quest for partnerships with both the public and the private sector. Overall, the adoption of QPBR – facilitated by these training manuals – will have the effect of promoting cost-effective, accelerated research with a long-term positive effect on the development of products for the improvement of human health.

(10)

4

This manual for trainees is part of a suite of three documents produced by WHO / TDR : 1. Quality Practices in Basic Biomedical Research Handbook (orange)

2. Quality Practices in Basic Biomedical Research Training Manual – for the Trainee (turquoise)

3. Quality Practices in Basic Biomedical Research Training Manual – for the Trainer (brown)

Production of the two training manuals was made possible by the enthusiastic support of and contributions from WHO/TDR and the participants in scientific working groups set up under the auspices of WHO/TDR and collaborators.

Our thanks are also extended to those who helped in the production of the Quality Practices in Basic Biomedical Research Handbook, on which the training manuals are based.

Sincere thanks go to Nadya Gawadi and David Long for their role in drafting this manual.

Comments and suggestions on all aspects of these QPBR training manuals are welcome for consideration in future revisions. Please contact :

Dr Deborah Kioy TDR

World Health Organization Avenue Appia 20

Geneva 27 – Switzerland Tel : + 41 22 791 3524 Fax : + 41 22 791 4854 E-mail : kioyd@who.int

(11)

5

INTRODUCTION

The quality practices in basic biomedical research (QPBR) training manual is an accom- paniment to a two-day training course on the subject. The course is divided into six sessions – sessions 1, 2 and 3 are structured for the first day and sessions 4, 5 and 6 for the second.

The manual material has been put together to fit the six sessions (see contents page above).

How to use the WHO / TDR material

Course material :

WHO / TDR handbook on QPBR Trainee manual, including :

UÊÃiÌÊvÊ*ÜiÀ*ÌÊ«ÀiÃiÌ>ÌÊÃ`iÃÊ UÊÃÌÊvÊ}>ÃÊvÀÊi>VÊÃiVÌ

UÊÃiÌÊvÊµÕiÃÌÃÊvÀÊ`ÃVÕÃÃÊvÀÊi>VÊÃiVÌ

UÊÜÀÃ«ÊÃÕ}}iÃÌÃÊvÀÊi>VÊÃiVÌ

UÊV>ÃiÊÃÌÕ`iÃÊvÀÊ`ÃVÕÃÃÊ>ÌÊÌiÊi`ÊvÊÌiÊÌÀ>}ÊVÕÀÃi°

Goals

Each section has a set list of ambitious pedagogical goals – at the end of the course you should be able to formulate the requirements of QBPR in order to transmit and implement them (in dialogue with your respective research institutions). The more lively the discussions and exchanges between you and the other participants during this course, the more you will learn ; so contribute actively to all the workshop sessions and ask questions of the trainer.

The goals are set in a hierarchy from simple to complex cognitive skills : this is because you will be expected to complete an exceedingly complicated exercise (implementation of QPBR) when you return to your research institution. Simple knowledge of QBPR will not be sufficient for this task.

Bloom’s taxonomy of learning domains^* is used in the description of goals for each section.

This system is not new but can be used relatively simply to categorize the level of abstraction of tasks that occur in educational settings.

*From Bloom, Benjamin S.Taxonomy of educational objectives. Boston, MA : Allyn and Bacon. Copyright (c) Pearson Educa- tion 1984. Adapted by permission of the publisher. Table copied from University of Victoria web site (http : / / www.coun.

uvic.ca / learning / exams / blooms-taxonomy.html).

(12)

6

Competence Skills Demonstrated

Knowledge UÊLÃiÀÛ>ÌÊ>`ÊÀiV>ÊvÊvÀ>ÌÊ UÊÜi`}iÊvÊ`>ÌiÃ]ÊiÛiÌÃ]Ê«>ViÃÊ UÊÜi`}iÊvÊ>ÀÊ`i>ÃÊ

UÊ>ÃÌiÀÞÊvÊÃÕLiVÌÊ>ÌÌiÀÊ

Question Cues :

list, define, tell, describe, identify, show, label, collect, examine, tabulate, quote, name, who, when, where, etc.

Comprehension UÊÕ`iÀÃÌ>`}ÊvÀ>ÌÊ UÊ}À>Ã«Êi>}Ê

UÊÌÀ>Ã>ÌiÊÜi`}iÊÌÊiÜÊVÌiÝÌÊ UÊÌiÀ«ÀiÌÊv>VÌÃ]ÊV«>Ài]ÊVÌÀ>ÃÌÊ UÊÀ`iÀ]Ê}ÀÕ«]ÊviÀÊV>ÕÃiÃÊ

UÊ«Ài`VÌÊVÃiµÕiViÃÊ

Question Cues :

summarize, describe, interpret, contrast, predict, associate, distinguish, estimate, differentiate, discuss, extend

Application UÊÕÃiÊvÀ>ÌÊ

UÊÕÃiÊiÌ`Ã]ÊVVi«ÌÃ]ÊÌiÀiÃÊÊiÜÊÃÌÕ>ÌÃÊ UÊÃÛiÊ«ÀLiÃÊÕÃ}ÊÀiµÕÀi`ÊÃÃÊÀÊÜi`}iÊ

Questions Cues :

apply, demonstrate, calculate, complete, illustrate, show, solve, examine, modify, relate, change, classify, experiment, discover

(13)

7

Introduction UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINEE

Analysis UÊÃii}Ê«>ÌÌiÀÃÊ UÊÀ}>â>ÌÊvÊ«>ÀÌÃÊ

UÊÀiV}ÌÊvÊ``iÊi>}ÃÊ UÊ`iÌvV>ÌÊvÊV«iÌÃÊ

Question Cues :

analyse, separate, order, explain, connect, classify, arrange, divide, compare, select, explain, infer

Synthesis UÊÕÃiÊ`Ê`i>ÃÊÌÊVÀi>ÌiÊiÜÊiÃÊ UÊ}iiÀ>âiÊvÀÊ}ÛiÊv>VÌÃÊ

UÊÀi>ÌiÊÜi`}iÊvÀÊÃiÛiÀ>Ê>Ài>ÃÊ UÊ«Ài`VÌ]Ê`À>ÜÊVVÕÃÃÊ

Question Cues :

combine, integrate, modify, rearrange, substitute, plan, create, design, invent, what if ? compose, formulate, prepare, generalize, rewrite

Evaluation UÊV«>ÀiÊ>`Ê`ÃVÀ>ÌiÊLiÌÜiiÊ`i>ÃÊ UÊ>ÃÃiÃÃÊÛ>ÕiÊvÊÌiÀiÃ]Ê«ÀiÃiÌ>ÌÃÊ UÊ>iÊVViÃÊL>Ãi`ÊÊÀi>Ãi`Ê>À}ÕiÌÊ UÊÛiÀvÞÊÛ>ÕiÊvÊiÛ`iViÊ

UÊÀiV}âiÊÃÕLiVÌÛÌÞÊ

Question Cues :

assess, decide, rank, grade, test, measure, recommend, convince, select, judge, explain, discriminate, support, conclude, compare, summarize

(14)

8

1.1 QUALITY PRACTICES IN BASIC BIOMEDICAL RESEARCH

Goals

At the end of the session, you should be able to :

UÊ `iviÊL>ÃVÊLi`V>ÊÀiÃi>ÀVÊ>`Ê«>ViÊÌÊÊVÌiÝÌÊÜÌÊ>ÌiÀÊÃÌ>}iÊÀiÃi>ÀVÊÆ UÊ `iÃVÀLiÊV>}iÃÊÊÌiÊÃV>Ê>`Ê>ÌÕÀ>ÊiÛÀiÌÊÌ>ÌÊ>ÀiÊ>VViiÀ>Ì}Êi>ÌÊ

problems today ;

UÊ «ÀiÃiÌÊÌiÊV>ÃiÊvÀÊ+* ,Ê}Õ`iiÃÊ>ÃÊ>Ê>`ÊÌÊÃiiVÌÊvÊiÜÊ«ÀiVÌÃÊ>`ÊvÀÊ the acceptance of new products / principles ;

UÊ `iÃVÀLiÊ>`ÊiÝi«vÞÊÌiÊ`vviÀiViÊLiÌÜiiÊÌiÊÃViÌvVÊVÌiÌÊ>`ÊÌiÊ«À>VÌV>Ê performance of research studies ;

UÊ ÀiV}âiÊÌiÊÃÌ>}iÃÊvÊLi`V>ÊÀiÃi>ÀVÊ>`Ê}ÛiÊiÝ>«iÃÊvÀÊiÛiÀÞ`>ÞÊ«À>VÌViÊ or examples that do not fit the model (include drug products, other products and / or principles for new therapies or strategies).

(15)

9

Session 1 UÊ+* ,Ê/À>}Ê>Õ>Ê TRAINEE

Session 1:1:2 Session 1:1:1

(16)

10

(17)

11

Session 1:1:5

(18)

12

(19)

13

(20)

14

(21)

15

(22)

16

(23)

17

Session 1:1:17

(24)

18

Questions

UÊ 7>ÌÊÃÊL>ÃVÊLi`V>ÊÀiÃi>ÀVÊ¶ÊÛiÊ>ÊiÝ>«iÊvÀÊÞÕÀÊÜÊiÝ«iÀiVi°

UÊ 7>ÌÊÕÀ}iÌÊi>ÌÊV>i}iÃÊÃÊÌiÊÜÀ`Êv>V}Ê¶Ê>ÊÞÕÊ>``ÊÀiÊiÝ>«iÃÊ¶

UÊ 7ÞÊÃÊÌÊ`vvVÕÌÊÌÊ>ÌVÊÌiÊii`ÃÊvÀÊ«ÀiÛiÌÊ>`ÊÌÀi>ÌiÌÊÜÌÊ>ÊÃÕ««ÞÊvÊ new products and / or principles to combat disease and other threats to health ? UÊ 7ÞÊ>ÀiÊ}Õ`iiÃÊvÀÊL>ÃVÊÀiÃi>ÀVÊi«vÕÊÊi>L}ÊÌiÊÃÕ««ÞÊvÊiÜÊ«À`ÕVÌÃÊ

and / or principles to combat disease and other threats to health ?

UÊ iÃVÀLiÊÌiÊÃV«iÊvÊÌiÊ+* ,Ê}Õ`iiÃ°Ê iÊÃ«iVvVÊ>LÕÌÊÜ>ÌÊÃÊ>`ÊÜ>ÌÊÃÊÌÊ addressed.

UÊ 7ÞÊ ÜÕ`Ê }Õ`iiÃÊ v>VÌ>ÌiÊ ÌiÊ `iVÃ>}Ê «ÀViÃÃÊ vÀÊ vÕ`}Ê iÜÊ projects ?

UÊ 7>ÌÊÃÊvÀ>Õ`ÕiÌÊÀiÃi>ÀVÊ¶Ê7Õ`ÊÌiÊÕÃiÊvÊ}Õ`iiÃÊ`ÃVÕÀ>}iÊvÀ>Õ`ÊÊL>ÃVÊ biomedical research ?

UÊ 7>ÌÊÃÊi>ÌÊLÞÊÀi}Õ>Ìi`ÊÀiÃi>ÀVÊ¶ÊÛiÊiÝ>«iÃÊvÊÃiÊvÊÌiÊÀi}Õ>ÌÃÊ>`Ê what they cover.

UÊ 7iÀiÊ`iÃÊ+* ,ÊvÌÊÌÊÌiÊÃÌ>}iÃÊvÊ`ÀÕ}Ê`iÛi«iÌÊÀiÃi>ÀVÊ¶

UÊ 7>ÌÊ«>ÃiÃÊV«ÀÃiÊL>ÃVÊLi`V>ÊÀiÃi>ÀVÊ¶

Workshops

1. Take an example of a research project from your everyday activity and place it in context as a stage in basic biomedical research. What activities preceded it and what will follow ?

What is the aim of this project and what studies are involved ? How will you con- solidate the results for transition to the next stage ? Are all the studies in the project at the same stage of basic research ?

Present your discussion using the flip chart or board for diagrams, flow charts or any other presentation you prefer.

2. Use a flip chart to draw up a flow chart showing the different research and development stages for a new drug. Indicate the places at which QPBR and regulatory texts impact the development pathway.

(25)

19

1.2 WHAT IS QUALITY IN RESEARCH ?

Goals

At the end of the session, you should be able to : UÊ `iviÊºÊµÕ>ÌÞÊ»ÊÊ}iiÀ>ÊÌiÀÃÊÆ

UÊ iÝ«>Ê ÌiÊ `vviÀiViÊ LiÌÜiiÊ ÌiÊ ÃViÌvVÊ VÌiÌÊ >`Ê ÌiÊ «À>VÌV>]Ê À}>â>- tional aspects of experimental science ;

UÊ `iviÊÌiÊ«ÕÀ«ÃiÊvÊ+* ,ÊÊÌiÀÃÊvÊ`>Ì>ÊÀi>LÌÞÊ>`Ê>``i`ÊÛ>ÕiÊÆ

UÊ ÃÌÊÌiÊµÕ>ÌÞÊ>ÌÌÀLÕÌiÃÊvÊL>ÃVÊLi`V>ÊÀiÃi>ÀVÊ>`ÊÕÌiÊÌiÀÊi>}ÃÊÆ UÊ `iÃVÀLiÊÌiÊÃÀÌÊvÊ>VÌÛÌÞÊÌ>ÌÊÌiÊÃViÌvVÊVÕÌÞÊÕÃiÃÊÌÊÛ>`>ÌiÊÃÌÕ`iÃÊ>`Ê

data ;

UÊ ÕÌiÊ>ÊÃiÌÊvÊÛ>À>LiÃÊ>vviVÌ}Ê>ÊÃÌÕ`Þ]Ê«ÃÃLÞÊÌÀ`ÕV}ÊL>ÃÊÆ

UÊ >À}ÕiÊvÀÊÌiÊ«ÀÌ>ViÊvÊV>ÀivÕÊ«>}Ê>`Ê>ÊÜÀÌÌiÊ«>ÊvÀÊi>VÊÃÌÕ`ÞÊÆ UÊ ÃÕ>ÀâiÊÌiÊV>ÃiÊvÀÊÕÃ}ÊÃÌ>`>À`Ê«ÀVi`ÕÀiÃÊvÀÊÀÕÌiÊ>VÌÛÌiÃÊÆ

UÊ iÝ«>Ê ÜÞÊ >Ê >i`Ê `Û`Õ>Ê ii`ÃÊ ÌÊ Ì>iÊ }iÛiÊ ÀiÃ«ÃLÌÞÊ vÀÊ ÌiÊ design and conduct of a study ;

UÊ iÝ«>ÊÌiÊ«ÕÀ«ÃiÊvÊVÌÀÃÊÆ

UÊ >ÃÃiÃÃÊVÀÌV>ÞÊÜÊÛ>À>LiÃÊvÕiViÊÃÌÕ`ÞÊÀiÃÕÌÃÊÆ UÊ `iÃVÀLiÊÌiÊÀi>ÌÃ«ÊLiÌÜiiÊ«>]ÊÃÌÕ`ÞÊ>`Ê`>Ì>ÊÆ

UÊ `iÃVÀLiÊ >Ê ÀiÃi>ÀViÀ½ÃÊ ii`ÃÊ vÀÊ Ài«iÌÌÊ vÊ >Ê ÃÌÕ`Þ]Ê i°}°Ê Ê ÌiÀÃÊ vÊ `>Ì>Ê >`Ê documents.

(26)

20

(27)

21

Session 1:2:3

Session 1:2:4

(28)

22

(29)

23

Session 1:2:7

Session 1:2:8

(30)

24 24

(31)

25

Session 1:2:11

Session 1:2:12

(32)

26

(33)

27

Session 1:2:15

Session 1:2:16

(34)

28

(35)

29

Session 1:2:19

(36)

30

Questions

ÊUÊ 7>ÌÊ>ÀiÊÌiÊÌÜÊ>Ã«iVÌÃÊvÊÀiÃi>ÀVÊµÕ>ÌÞÊ¶Ê7>ÌÊ`iÃÊi>VÊ>Ã«iVÌÊVÌÀLÕÌiÊÌÊ the total quality ?

ÊUÊ 7>ÌÊÃÊÌiÊ«ÕÀ«ÃiÊvÊ+* ,Ê¶Ê

ÊUÊ ÃÊÌiÀiÊ>Ê«À>VÌV>Ê>`Û>Ì>}iÊÌÊ>}ÊÃÕÀiÊÌ>ÌÊÞÕÀÊÀiÃi>ÀVÊÜÀÊÃÊÜiÀ}>âi`Ê¶

ÊUÊ 7>ÌÊÛ>ÕiÊ`iÃÊÜiÀ}>âi`ÊÀiÃi>ÀVÊ`ÊvÀÊÌiÀÊÀiÃi>ÀViÀÃÊ¶

ÊUÊ 7>ÌÊÃÊÌiÊ`ivÌÊvÊºÊµÕ>ÌÞÊ»ÊÊ+* ,Ê¶ÊÊÞÕÊ>}ÀiiÊ¶ÊÀiÊÌiÀiÊÌiÀÊi>}ÃÊ¶Ê ÊUÊ 7>ÌÊ>ÀiÊÌiÊµÕ>ÌÞÊV>À>VÌiÀÃÌVÃÊvÊÃViÌvVÊÀiÃi>ÀVÊ¶

ÊUÊ >ÊÞÕÊLÀivÞÊ`iviÊi>VÊiÊ¶

ÊUÊ 7>ÌÊ>ÀiÊiÝ«iÀiÌ>ÊÛ>À>LiÃÊ¶Ê

ÊUÊ 7>ÌÊÃÊÌiÊiÃÃ>}iÊvÊÌiÊÌÜÊiÝ>«iÃÊ}ÛiÊ¶

ÊUÊ 7ÞÊÃÕ`ÊÞÕÊÃ«i`ÊÌiÊÊ>ÊÜÀÌÌiÊ«>Ê¶

ÊUÊ 7>ÌÊÃÀÌÊvÊvÀ>ÌÊÜÕ`ÊÞÕÊVÕ`iÊÌÊ`iÃVÀLiÊÉÊVÌÀÊÛ>À>LiÃÊ¶ÊÛiÊÌÜÊ or three examples.

ÊUÊ ÜÊ`iÃÊÌiÊvÀ>ÌÊÊÌiÊÃÌÕ`ÞÊ«>Ê`vviÀÊvÀÊÌiÊvÀ>ÌÊÊÌiÊ`>Ì>Ê¶Ê ÊUÊ Ý«>ÊÌiÊÌi`i`ÊÃV«iÊvÊ+* ,]ÊVÕ`}ÊÜ>ÌÊÃÊÌÊVÛiÀi`°

Workshops

1. List the quality attributes of two or three everyday products or services (e.g. a drinking cup, cup of coffee, road, weather forecast, organizing a holiday). Could different examples of the same sort of product have different quality attributes ? List your examples and their quality attributes on the flip chart.

2. List the quality attributes for basic biomedical research. Is this an exhaustive list ? Write down what each attribute means in practical, behavioural terms.

3. Taking one or two studies from your everyday experience write a list of possible sources of bias and discuss measures you could take to minimize artefact to ensure the validity of your data. Present your discussion schematically on the flip chart / board.

4. Give an example of doubtful scientific results in your everyday activity or from the scientific literature. Was the failure due to scientific problems ? Problems with experimental conduct / data ? A mixture of both ? Or something quite different ? Use the flip chart to summarize your discussion as a table showing the type of failure and the actual circumstances.

(37)

31

SESSION 2

2.1 ORGANIZATION

Goals

At the end of the session, you should be able to : UÊ iÝ«>ÊÜÞÊ>ÊvÀ>ÊÀ}>â>ÌÊÃÊii`i`ÊÆ

UÊ >À}ÕiÊvÀÊÌiÊ>`Û>Ì>}iÃÊvÊ>ÊVi>ÀÊ>V>ÌÊvÊÀiÃ«ÃLÌiÃÊ>`Ê>VÌÛÌiÃÊÆÊ UÊ `iÃVÀLiÊ>>}iiÌ½ÃÊÀiÃÊ>`ÊÀiÃ«ÃLÌiÃÊÆÊ

UÊ ÃÕ>ÀâiÊÌiÊViVÃÊ>`ÊL>>ViÃÊ«VÌÊÊÌiÊÕÃiÊvÊ«iiÀÊÀiÛiÜÊ>`ÊµÕ>ÌÞÊ assurance (QA) surveillance ;

UÊ iÝ«>ÊÌiÊ«À>VÌV>Ê«ÕÀ«ÃiÊvÊÌiÊ`VÕiÌÃÊÛÛi`Ê\ÊµÕ>ÌÞÊ«VÞ]ÊÀ}>â>- tional chart, job description, curriculum vitae (CV) ;

UÊ «À`ÕViÊ>Ê`iÊLÊ`iÃVÀ«ÌÊvÀÊÌÀiiÊ`vviÀiÌÊÀiÃ°

(38)

32

(39)

33

(40)

34

Session 2:1:5

Session 2:1:6

(41)

35

(42)

36

Session 2:1:9

Session 2:1:10

(43)

37

(44)

38

Questions

ÊUÊ 7ÊÃÕ`ÊÃÃÕiÊ>ÊµÕ>ÌÞÊÃÌ>ÌiiÌÊÉÊ«VÞÊ¶Ê7ÞÊÃÕ`ÊÌiÞÊ`ÊÌÃÊ¶

ÊUÊ 7>ÌÊ>ÀiÊÌiÊÕÊÀiÃÊiiì`ÊvÀÊÃÌÕìÃÊ«iÀvÀi`ÊÕìÀÊ+* ,Ê¶

ÊUÊ 7ÞÊÃÊÌiÊ«ÀV«>ÊÃViÌÃÌÊ>ÊiÞÊ«ÃÌÊ¶ÊiÃVÀLiÊÌiÊÀiÃ«ÃLÌiÃÊ>`Ê>VÌÛÌiÃÊ of this person.

ÊUÊ 7ÊÃÊ+Ê¶Ê7>ÌÊ>ÀiÊ+½ÃÊ>ÊÀiÃ«ÃLÌiÃÊ¶Êì>Þ]Ê+ÊÃÕ`ÊLiÊì«iìÌÊ of the organization performing scientific study activities – why ?

ÊUÊ 7>ÌÊ>ÀiÊÌiÊ«ÕÀ«ÃiÃÊvÊ>ÊLÊ`iÃVÀ«ÌÊ¶

ÊUÊ 7ÞÊ`iÃÊ>ÊÃÌÌÕÌÊii`ÊÌÊii«Ê6ÃÊvÀÊ>ÊÃÌ>vvÊ¶

ÊUÊ 7ÞÊ ÃÊ ÌÀ>}Ê >Ê VÀiÊ >VÌÛÌÞÊ vÀÊ >ViÛ}Ê }Ê µÕ>ÌÞÊ Ê L>ÃVÊ Li`V>Ê research ?

ÊUÊ 7ÞÊÃÕ`ÊÌÀ>}ÊLiÊ`VÕiÌi`Ê¶Ê

ÊUÊ 7ÞÊÃÊÌÊ«ÀÌ>ÌÊÌÊii«ÊÌÀ>}ÊÀiVÀ`ÃÊvÀÊ«iÀÃiÊ¶

Workshops

1. Taking one of your own (or your department’s) studies as an example, describe what roles are active and who (job title) occupies these roles. Tabulate responsibilities, roles and job titles. Identify any roles that are missing ; situations in which two people appear responsible for the same activity ; or responsibilities that are not covered.

2. In your discussion group, for each of your institutions, make a chart showing the inci- dence of the following : a quality policy, a QA group, routine use of peer review, use of job descriptions, use of training records. If any of these are missing, how would you propose to introduce them ?

3. Write job descriptions for one or two persons in the group (bullet points rather than full text), using the points mentioned in slide 11 of the PowerPoint presentation on organization and quality.

4. Write a job description for the managers or assistants of one or two other persons in the group.

(45)

39

2.2 PHYSICAL RESOURCES

Goals

ÊUÊ ìÃVÀLiÊ«ÀÌ>ÌÊv>VÌÀÃÊÌÊVÃìÀÊÜiÊLÕ`}ÊiÜÊv>VÌiÃÊÆ ÊUÊ >À}ÕiÊvÀÊÌiÊ«ÀÌ>ViÊvÊÃi«>À>Ì}Ê>VÌÛÌiÃÊÊÀiÃi>ÀVÊv>VÌiÃÊÆ ÊUÊ ìviÊ`vviÀiÌÊÜ>ÞÃÊvÊÃi«>À>Ì}Ê>VÌÛÌiÃÊÆ

ÊUÊ «ÀÛ`iÊ iÝ>«iÃÊ Ê ÜVÊ Ãi«>À>ÌÊ vÊ ÀiÃi>ÀVÊ >VÌÛÌiÃÊ ÃÊ vÕ`>iÌ>Ê ÌÊ ÌiÊ integrity of research ;

ÊUÊ `vviÀiÌ>ÌiÊLiÌÜiiÊÌiÊÃViÌÃÌ½ÃÊÀiÃ«ÃLÌÞÊvÀÊ`iV`}ÊÜ>ÌÊiµÕ«iÌÊÌÊÕÃiÊ and the need to ensure that all equipment functions correctly ;

ÊUÊ >À}ÕiÊ vÀÊ ÌiÊ ii`Ê ÌÊ «iiÌÊ V>LÀ>ÌÊ >`Ê >Ìi>ViÊ «ÀVi`ÕÀiÃÊ ÜÌÊ >Ê research organization ;

ÊUÊ `ÃÌ}ÕÃÊLiÌÜiiÊ«ÀiÛiÌÛiÊ>Ìi>ViÊ>`ÊÀi«>ÀÊÆ

ÊUÊ `iÃVÀLiÊ Ü>ÌÊ `VÕiÌÃÊ >ÀiÊ ii`i`Ê ÌÊ iÃÕÀiÊ vÕÊ ÌÀ>Vi>LÌÞÊ vÊ V>LÀ>ÌÊ >`Ê maintenance ;

ÊUÊ `iÃVÀLiÊÌiÊVÌiÌÊ>`ÊÕÃiÊvÊ>Êv>ÕÌÊ>VÌÊÀi«ÀÌ°

(46)

40

(47)

41

Session 2:2:3

Session 2:2:4

(48)

42

(49)

43

Session 2:2:7

Session 2:2:8

(50)

44

(51)

45

Session 2:2:11

Session 2:2:12

(52)

46

(53)

47

Session 2:2:15

Session 2:2:16

(54)

48

Questions

ÊUÊ 7>ÌÊÃÊÃi«>À>ÌÊvÊ>VÌÛÌiÃÊÜÌÊ>Êv>VÌÞÊ¶Ê7ÞÊÃÊÌÃÊVVi«ÌÊ«ÀÌ>ÌÊvÀÊ the integrity of research ?

ÊUÊ ÛiÊiÝ>«iÃÊÌÊÃÜÊÜÊ>ÊÀiÃi>ÀVÊ«ÀiVÌÊVÕ`ÊLiÊV«ÀÃi`ÊLÞÊv>ÕÀiÊÌÊ separate research activities.

ÊUÊ ÛiÊiÝ>«iÃÊvÊ«ÞÃV>ÊÃi«>À>ÌÃÊvÀiµÕiÌÞÊvÕ`ÊÊ>ÊÀiÃi>ÀVÊiÛÀiÌ°

ÊUÊ iÃÊÃi«>À>ÌÊvÊ>VÌÛÌiÃÊ>Ü>ÞÃÊÀiµÕÀiÊ«ÞÃV>ÊÃi«>À>ÌÊ¶ÊÊÜ>ÌÊÌiÀÊÜ>ÞÃÊ could this separation be achieved ?

ÊUÊ 7ÞÊÃÊÌiÊÃÕÌ>LÌÞÊvÊiµÕ«iÌÊÃ>`ÊÌÊLiÊ>ÊÃViÌvVÊÀiÃ«ÃLÌÞÊÀ>ÌiÀÊÌ>Ê an aspect of quality management ?

ÊUÊ 7>ÌÊÃÊÌiÊ`vviÀiViÊLiÌÜiiÊ>Ê«À>ÀÞÊ>`Ê>ÊÃiV`>ÀÞÊÜÀ}ÊÃÌ>`>À`Ê¶

ÊUÊ 7>ÌÊ-"*ÃÊ`ÊÞÕÊÌÊ>ÀiÊÀiµÕÀi`ÊvÀÊiµÕ«iÌÊÕÃi`ÊÊ>Ê>LÀ>ÌÀÞÊ¶

ÊUÊ ÛiÊÃiÊiÝ>«iÃÊvÊ«ÀiÛiÌÛiÊ>Ìi>ViÊ«iÀvÀi`ÊÊÞÕÀÊÜÊÀ}>â>Ì°

ÊUÊ 7>ÌÊi>`}ÃÊÃÕ`ÊLiÊVÕ`i`ÊÊ>Êv>ÕÌÊ>VÌÊÀi«ÀÌÊ¶Ê7ÊÜÕ`ÊÜÀÌiÊÌÊ¶Ê To whom should it be sent ?

ÊUÊ 7>ÌÊÜÕ`Ê>ÊÃÌ>`>À`Ê}LÊVÌ>Ê¶

ÊUÊ 7>ÌÊÜÕ`Ê>ÊÃÌ>`>À`Ê>««>À>ÌÕÃÊviÊVÌ>Ê¶

(55)

49

Workshops

1. Taking as examples two different pieces of equipment with which you are familiar, use a flip chart to describe :

a. how you would determine suitability for use

b. how you would recommend that calibration be performed

c. documents you would consider necessary to support the traceability of all actions involving the equipment.

2. Consider a secondary standard used in your laboratory. Use a flip chart to map out the process by which it is linked to (a) a primary standard ; and eventually (b) a national standard.

3. List on a flip chart the information / documents that you would require from an out- side contractor called in to service an identified piece of equipment that has broken down. What would you do with these documents ?

4. Design a standard fault action report for your facility.

5. You have been asked to design and equip a laboratory which will be used for analytical work, including general analysis (potentiometry, high performance liquid chroma- tography [HPLC] etc.), microbiology and stability studies. List the points that you consider essential for drawing up a requirements document that will form the basis for requests for tenders from architects.

(56)

50

3.1 DOCUMENTATION – OVERVIEW

Goals

ÊUÊ iÝ«>ÊÜÞÊvÕÊ`VÕiÌ>ÌÊÃÊViÌÀ>ÊÌÊÌiÊÛ>ÕiÊvÊ>ÊÃÌÕ`ÞÊÆ

ÊUÊ ìviÊ«ÀiÃVÀ«ÌÛiÊ>`ÊìÃVÀ«ÌÛiÊ`VÕiÌÃÊ>`Ê}ÛiÊiÝ>«iÃÊvÊi>VÊÌÞ«iÊÆ ÊUÊ «ÀÛìÊ Ê ÃVi>ÌVÊ vÀÊ ÌiÊ Ài>ÌÃ«Ê LiÌÜiiÊ «ÀiÃVÀ«ÌÛiÊ >`Ê ìÃVÀ«ÌÛiÊ

documents and their relationship to the practical study activities ; ÊUÊ iÝ«>ÊÜÞÊvÕÊÀiVÀ`ÃÊ>ÀiÊiViÃÃ>ÀÞÊvÀÊÃÌÕ`ÞÊÀiVÃÌÀÕVÌÊÆ

ÊUÊ `iÃVÀLiÊÌiÊÀi>ÌÃ«ÊLiÌÜiiÊÃÌÕ`ÞÊ`>Ì>Ê>`ÊÌiÊÃÌÕ`ÞÊ«>Ê>`ÊiÝ«>ÊÜ>ÌÊ>Ê study file is ;

ÊUÊ `iÃVÀLiÊÌiÊÀi>ÌÃ«ÊLiÌÜiiÊ>ÊÃÌÕ`ÞÊÀi«ÀÌÊ>`Ê>Ê«ÕLV>ÌÊÆ ÊUÊ >À}ÕiÊvÀÊvÀ>âi`ÊÃÌÀ>}iÊvÊÃÌÕ`ÞÊ`VÕiÌ>Ì°

(57)

51

Session 3:1:1

Session 3:1:2

(58)

52 52

(59)

53

Session 3:1:5

Session 3:1:6

(60)

54 54

(61)

55

Session 3:1:9

Session 3:1:10

(62)

56 56

(63)

57

Questions

Why is full study documentation essential to the validity of a study ?

ÊUÊ >ÊÞÕÊ}ÛiÊiÝ>«iÃÊvÊÃÌÕ`iÃÊÊÜVÊÌiÊÃViÌvVÊÌiÀ«ÀiÌ>ÌÊÜ>ÃÊ`ÕLÌvÕÊ because records were incomplete ?

ÊUÊ 7>ÌÊ>ÀiÊÌiÊiÃÃiÌ>ÊV>À>VÌiÀÃÌVÃÊvÊ«ÀiÃVÀ«ÌÛiÊ>`Ê`iÃVÀ«ÌÛiÊ`VÕiÌÃÊ¶

ÊUÊ ÛiÊ iÝ>«iÃÊ vÊ «ÀiÃVÀ«ÌÛiÊ >`Ê `iÃVÀ«ÌÛiÊ `VÕiÌÃÊ Ì>ÌÊ >ÀiÊ ÕÃi`Ê Ê ÞÕÀÊ laboratory.

ÊUÊ 7>ÌÊÃÊÌiÊvÕVÌÊvÊi>VÊ`VÕiÌÊÊÃ`iÊÈÊvÊÌiÊiVÌÕÀiÊÊ`VÕiÌ>ÌÊ¶

ÊUÊ 7iÀiÊ`iÃÊÞÕÀÊÃÌÌÕÌÊ>ÃÊÞÕÊÌÊii«ÊÃÌÕ`ÞÊÀiVÀ`ÃÊ¶

Workshops

1. Use a flip chart to draw up a flow chart that shows the relationships between a research proposal, study plan, study data, study report and publication(s) concerning the research programme. List some of the materials you would expect to have generated by the end of a study (the study file). How soon after the end of the study should the material be archived ? For how long should each type of material be stored ?

2. In practical terms, how would management ensure the safe keeping of study documentation ? Use the flip chart to draw up a to-do list for management.

3. In practical terms, how would management ensure the safe keeping of study documentation ? Use the flip chart to draw up a to-do list for management.

(64)

58

3.2 PRESCRIPTIVE DOCUMENTATION

Goals

ÊUÊ `iviÊ «ÀiÃVÀ«ÌÛiÊ `VÕiÌ>ÌÊ >`Ê ÌÃÊ Ài>ÌÃ«Ê ÌÊ ÌiÊ «À>VÌV>Ê >VÌÛÌiÃÊ vÊ studies ;

ÊUÊ >iÊÌiÊ`vviÀiÌÊ>ÞiÀÃÊvÊ«ÀiÃVÀ«ÌÛiÊ`VÕiÌ>ÌÊ>`Ê`iÃVÀLiÊÌiÀÊÀi>ÌÃ«Ê to one another ;

ÊUÊ `iÃVÀLiÊÌiÊ«ÕÀ«ÃiÃÊvÊÌiÃiÊÌÞ«iÃÊvÊ`VÕiÌÃÊ>`ÊÕÌiÊÌiÊ>««ÀÛ>Ê«ÀViÃÃÊ for each ;

ÊUÊ `iviÊÌi«>Ìi]Ê>ÞÕÌ]ÊvÀ>ÌÊ>`ÊVÌiÌÊÆ

ÊUÊ }ÛiÊ>ÊÕÌiÊvÊÌiÊÌÞ«iÃÊvÊvÀ>ÌÊÌÞ«V>ÞÊvÕ`ÊÊÀiÃi>ÀVÊ«À«Ã>ÃÊ>`Ê in study plans and define the relationship (using a diagram) between these two documents ;

ÊUÊ ìviÊÌiÊÀiÃ«ÃLÌiÃÊiViÃÃ>ÀÞÊvÀÊÌiÊ>««ÀÛ>Ê>`ÊÃÃÕiÊvÊ>ÊÃÌÕ`ÞÊ«>ÊÆ ÊUÊ `ÃÌ}ÕÃÊLiÌÜiiÊÃÌÕ`ÞÊ«>Ê>iìÌÃÊ>`ÊÃÌÕ`ÞÊìÛ>ÌÃÊÆ

ÊUÊ `iÃVÀLiÊÃÌÕ>ÌÃÊÊÜVÊÃÌÕ`ÞÊ«>ÃÊ>`Ê-"*ÃÊÃÕ`ÊLiÊÕÃi`ÊÆ ÊUÊ }ÛiÊiÝ>«iÃÊvÊ-"*ÃÊÆ

ÊUÊ `iÃVÀLiÊÌiÊ>ÌÌÀLÕÌiÃÊvÊ>Ê-"*Ê>>}iiÌÊÃÞÃÌiÊÆ

ÊUÊ Õ`iÀÃÌ>`ÊÜÊ-"*ÃÊVÌÀLÕÌiÊÌÊÌiÊL>ÃVÊÀiÃi>ÀVÊ«ÀViÃÃÊÆ

ÊUÊ >À}ÕiÊvÀÊÌiÊvÀii`Ê>`ÊÌi}ÀÌÞÊvÊÌiÊVÀi>ÌÛiÊÀiÃi>ÀVÊ«ÀViÃÃ]Ê`iÃ«ÌiÊÌiÊÕÃiÊ of SOPs.

(65)

59

Session 3:2:1

Session 3:2:2

(66)

60

(67)

61

Session 3:2:5

Session 3:2:6

(68)

62

(69)

63

Session 3:2:9

Session 3:2:10

(70)

64

(71)

65

Session 3:2:13

Session 3:2:14

(72)

66

(73)

67

Session 3:2:17

Session 3:2:18

(74)

68

(75)

69

Session 3:2:21

Session 3:2:22

(76)

70

(77)

71

Questions

ÊUÊ 7ÞÊ`ÊÞÕÊii`ÊÌÊ`VÕiÌÊÞÕÀÊÀiÃi>ÀVÊ>VÌÛÌiÃÊ¶

ÊUÊ ÜÊÜÕ`ÊÞÕÊÜÊÌ>ÌÊÌiÊ«ÌÃÊ>`ÊLiiÊi«ÌÊÉÊÃÃi`ÊÀÊÌ>ÌÊ`>Ì>Ê>ÀiÊV- plete / missing ?

ÊUÊ 7>ÌÊÃÊ>ÊÌi«>ÌiÊ¶Ê7>ÌÊÃÊÌiÊ`vviÀiViÊLiÌÜiiÊ>ÊÃÌ>`>À`ÊÀiÃi>ÀVÊ«À«Ã>Ê>Ê official form) and the content of a standard research proposal ?

ÊUÊ 7>ÌÊ`iÃÊ>ÊÃÌÕ`ÞÊ«>ÊVÌ>Ê¶ÊÌÀ>ÃÌÊÜÌÊ>ÊÀiÃi>ÀVÊ«À«Ã>°

ÊUÊ 7ÊÌ>iÃÊÛiÀ>ÊÃViÌvVÊ>`ÊÀ}>â>Ì>ÊÀiÃ«ÃLÌÞÊvÀÊÌiÊÃÌÕ`ÞÊ«>Ê>`Ê the conduct of the study ?

ÊUÊ ÜÊ`ÊÞÕÊ`i>ÊÜÌÊV>}iÃÊÌÊÌiÊÃÌÕ`ÞÊ«>Ê¶

ÊUÊ ÛiÊ>ÊiÝ>«iÊvÊÜ>ÌÊVÕ`ÊVÃÌÌÕÌiÊ>ÊÃÌÕ`ÞÊ«>Ê>i`iÌÊ>`ÊÜ>ÌÊÜÕ`Ê be classified as a study deviation. How would each of these be documented ? ÊUÊ ÜÊVÕ`ÊÞÕÊ«ÀiÃiÌÊÃÌÀÕVÌÃÊvÀÊ`iÌ>i`]ÊÀi«i>Ìi`Ê«ÀViÃÃiÃÊ¶

ÊUÊ 7ÞÊÃÊÌÊ«ÀÌ>ÌÊÌÊ>ÛiÊ-"*ÃÊ¶

ÊUÊ 7ÊÃÕ`ÊÜÀÌiÊÃÌ>`>À`Ê«iÀ>Ì}Ê«ÀVi`ÕÀiÃÊ¶

ÊUÊ 7>ÌÊ>ÀiÊÌiÊV>À>VÌiÀÃÌVÃÊvÊ>ÊÜi>>}i`Ê-"*Ê>>}iiÌÊÃÞÃÌiÊ¶

ÊUÊ >ÊÞÕÊ}ÛiÊÃiÊiÝ>«iÃÊvÊ«À>VÌV>Ê-"*ÃÊ>`Ê>`ÃÌÀ>ÌÛiÊ-"*ÃÊ¶

ÊUÊ 7Ê>««ÀÛiÃÊÌiÊVÌiÌÊ>`ÊÕÃiÊvÊ-"*ÃÊqÊ>`ÊÜÞÊ¶

ÊUÊ ÜÊ`ÊÞÕÊ`i>ÊÜÌÊV>}iÃÊÌÊ-"*ÃÊ¶

ÊUÊ 7>ÌÊÃÊÌiÊ`vviÀiViÊLiÌÜiiÊ>Ê-"*Ê>`Ê>ÊÃÌÀÕVÌÊivÌÊvÀÊ>ÊVi>}ÕiÊ¶Ê ÊUÊ 7Õ`Ê ÌÊ LiÊ Ài>Ã>LiÊ ÌÊ ÜÀÌiÊ >Ê -"*Ê vÀÊ >Ê «ÀVi`ÕÀiÊ Ì>ÌÊ ÃÊ >Ê ivvÊ Ê ÞÕÀÊ

laboratory ? If not, how would you document this ?

ÊUÊ >Ê>Ê>Õ>ÊLiÊÕÃi`ÊÌÊ}Õ`iÊi°}°ÊÕÃiÊvÊ>««>À>ÌÕÃ®Ê¶ÊÜÊÜÕ`ÊÌÃÊÜi`}iÊ be accessed some years after the event ?

(78)

72

Workshops

1. Taking two or three everyday processes as examples (e.g. making coffee, cleaning a bathroom, preparing a dinner party) make an outline for an SOP. Who would use these ? Present the outline on the flip chart.

2. You are an expert in a technique which is a standard practice in your research institute.

You are asked to write an SOP that will become the standard used by all the technical personnel who perform this technique.

Choose your domain of expertise and write an SOP (in summary form) for one particular standard procedure for the technique in question. You are not expected to write the SOP in detail but should provide an outline of the sections you would include and the contents of each section. An annotated table, organized set of bullet points or a detailed flow chart would be effective responses.

You may wish to look at the SOP template in QPBR for guidance on the format.

3. A non-controlled photocopy of an SOP was found pinned to the wall near the machine for which the SOP had been written. What are the possible unfortunate consequences ?

4. Sometimes it is claimed that the use of a study plan or the use of SOPs limits the creative imagination and weakens the research process. Do you agree ? What are the arguments for or against this view ?

5. For very short assays or tests it may be difficult to decide whether to use SOPs or study plans. Give examples and outline solutions. Discuss how to manage a one-off instruction.

6. Go through the SOP template and discuss the sections (including header and footer).

Use the flip chart to tabulate the sections and the purpose of each. If you were to implement SOPs at your workplace would you add more sections, leave out sections or do something else entirely ? For example, some organizations like to sign each page, some use electronic signatures, some keep to one page and some include a section on safety. Argue for your choice.

(79)

73

3.3 DESCRIPTIVE DOCUMENTATION – RAW DATA AND RECORDS

Goals

ÊUÊ ìviÊìÃVÀ«ÌÛiÊ`VÕiÌ>ÌÊ>`ÊÌÃÊÀi>ÌÃ«ÊÌÊÌiÊ«À>VÌV>Ê>VÌÛÌiÃÊÆ ÊUÊ >iÊÌiÊ`vviÀiÌÊ>ÞiÀÃÊvÊìÃVÀ«ÌÛiÊ`VÕiÌ>ÌÊ>`ÊìÃVÀLiÊÌiÀÊÌiÀÀi>-

tionships ;

ÊUÊ ìÃVÀLiÊÜ>ÌÊÃÊi>ÌÊLÞÊÀ>ÜÊ`>Ì>Ê>`Ê«ÀÛìÊiÝ>«iÃÊvÊÀ>ÜÊ`>Ì>Ê>`ÊìÀÛi`Ê data in a study from your everyday experience ;

ÊUÊ iÝ«>ÊÜ>ÌÊÃÊi>ÌÊLÞÊ>ÕÌiÌVÌÞÊÆ

ÊUÊ >ÃÃiÃÃÊÌiÊ>`Û>Ì>}iÃÊ>`Ê`Ã>`Û>Ì>}iÃÊvÊ>ÞÊ}ÛiÊ`>Ì>ÊViVÌÊiÌ`ÊÆ ÊUÊ ÕÌiÊÌiÊ>`Û>Ì>}iÃÊ>`Ê`Ã>`Û>Ì>}iÃÊvÊÕÃ}ÊV«ÕÌiÀÃÊÌÊViVÌÊ`>Ì>ÊÆ ÊUÊ `ÃVÕÃÃÊÜÊÌÊÀ}>âiÊVÌÀLÕÌÃÊvÀÊÃiÛiÀ>ÊÃViÌÃÌÃÊÆ

ÊUÊ `iÃVÀLiÊÌiÊVÌiÌÃÊvÊÃÌÕ`ÞÊÀiVÀ`ÃÊ>`ÊÌiÀÊÌiÀÀi>ÌÃ«Ã°

(80)

74

Session 3:3:1

Session 3:3:2

(81)

75

(82)

76

Session 3:3:5

Session 3:3:6

(83)

77

(84)

78

Session 3:3:9

Session 3:3:10

(85)

79

(86)

80

Session 3:3:13

Session 3:3:14

(87)

81

(88)

82

Session 3:3:17

(89)

83

Questions

ÊUÊ 7ÞÊ`ÊÞÕÊii`ÊÌÊ`VÕiÌÊÞÕÀÊÀiÃi>ÀVÊ>VÌÛÌiÃÊ¶

ÊUÊ 7>ÌÊ>Ã«iVÌÃÊvÊÌiÊÀiÃi>ÀVÊ«ÀViÃÃÊ`ÊÌiÊ`>Ì>ÊÃÕ««ÀÌÊ¶

ÊUÊ 7>ÌÊÃÊi>ÌÊLÞÊÀ>ÜÊ`>Ì>Ê¶

ÊUÊ ÀiÊÌiÀiÊÌiÀÊÌÞ«iÃÊvÊ`>Ì>Ê¶

ÊUÊ 7>ÌÊ>ÀiÊÌiÊÕÊ`iÌviÀÃÊvÊ>ÕÌiÌVÊÀ>ÜÊ`>Ì>Ê¶

ÊUÊ 7ÞÊÃÊÌÊ«ÀÌ>ÌÊÌÊViVÌÊ`>Ì>Ê«À«ÌÞÊ¶Ê7>ÌÊiÃiÊV>À>VÌiÀâiÃÊ}`ÊÀ>ÜÊ`>Ì>Ê capture ?

ÊUÊ 7>ÌÊ>ÀiÊÌiÊ>`Û>Ì>}iÃÊÊÉÊ`Ã>`Û>Ì>}iÃÊvÊÕÃ}ÊÃi]Ê«Ài«ÀÌi`Ê`>Ì>ÊÃiiÌÃÊ¶

ÊUÊ 7>ÌÊ>ÀiÊÌiÊ>`Û>Ì>}iÃÊÊÉÊ`Ã>`Û>Ì>}iÃÊvÊÕÃ}ÊÌiLÃÊ¶

ÊUÊ 7>ÌÊÜÕ`ÊÞÕÊ`ÊvÊÞÕÊÀi>âi`ÊÌ>ÌÊÌiÊÀ>ÜÊ`>Ì>ÊÜiÀiÊVÀÀiVÌÊ¶

ÊUÊ 7>ÌÊÃÊi>ÌÊLÞÊÃÌÕ`ÞÊviÊ¶Ê7>ÌÊÃÊÌiÊÕÊVÌiÌÊvÊ>ÊÃÌÕ`ÞÊviÊ¶

ÊUÊ ÜÊ`ÊÃÌÕ`ÞÊÀi«ÀÌÃÊÀi>ÌiÊÌÊÀ>ÜÊ`>Ì>Ê¶

ÊUÊ ÊÞÕÊÕÃiÊV«ÕÌiÀÃÊÌÊV>«ÌÕÀiÊ`>Ì>Ê¶

ÊUÊ Ê ÞÕÊ ÃÌÀiÊ À>ÜÊ `>Ì>Ê Ê ÌiÊ V«ÕÌiÀÊ¶Ê ÀiÊ ÌiÀiÊ >ÞÊ Ã«iV>Ê «ÀiV>ÕÌÃÊ ÌÊ observe, given that a study loses validity if data are lost ?

ÊUÊ 7>ÌÊÌiÀÊÀ>ÜÊ`>Ì>Ê}ÌÊLiÊiViÃÃ>ÀÞÊÌiÀÊÌ>ÊÀ>ÜÊ`>Ì>Ê«iÀÌ>}ÊÌÊÌiÊÃÌÕ`ÞÊ¶®

Workshops

1. Taking one of your own studies as an example, make a list of the raw data param- eters you collected and the format in which they were collected (i.e. data sheet, notebook, computer, machine output). Use a flow chart to follow the route of each parameter to the report (i.e. conversions, computer processing, statistics).

2. Design a raw data form for the collection of blood samples that are to be sent to a bioanalytical laboratory for analysis.

3. Do you perform the experiments with other people ? If so, how is data collection organized ? How can the scientists understand each other’s contribution and how is data checking performed ? In your discussion group compare your ways of organizing this process. Present verbally.

4. How does your organization check the authenticity of data ? How does it check accuracy ? Make a list of activities on the flip chart.

(90)

84

5. What would you do if you realized the data were incorrect – at the moment of collection ? A day later ? One month later ? After the report is issued ? After publication ? Use the flip chart to tabulate these time points and the sort of action you consider appropriate.

6. Taking one of your own studies as an example, list the contents of the study records (= study file) and present on the flip chart. Divide the documents into prescriptive and descriptive.

3.4 DOCUMENTATION – REPORTS AND STORAGE

Goals

ÊUÊ iÝ«>ÊÜÞÊÌÊÃÊ«ÀÌ>ÌÊÌÊ«ÀÌiVÌÊÃÌÕ`ÞÊ`VÕiÌ>ÌÊ`ÕÀ}ÊÌiÊÜiÊVÕÀÃiÊ of the study and after the report is complete ;

ÊUÊ V>Ìi}ÀâiÊÀi«ÀÌÃÊÌÊ«ÀiÃVÀ«ÌÛiÊ>`Ê`iÃVÀ«ÌÛiÊ`VÕiÌÃÊÆÊ

ÊUÊ iÝ«>ÊÌiÊÀi>ÌÃ«ÊLiÌÜiiÊ`Û`Õ>ÊÃÌÕ`ÞÊÀi«ÀÌÃ]Ê>ÀÌViÃÊÊÌiÊÌiÀ>ÌÕÀiÊ and the global account of an entire research project ;

ÊUÊ `iÃVÀLiÊÊ}iiÀ>ÊÌiÀÃÊÜ>ÌÊV«ÀÃiÃÊ>ÊÃÌÕ`ÞÊÀi«ÀÌÊÆ

ÊUÊ Ã«iVvÞÊÌiÊ`Û`Õ>ÊÀiÃ«ÃLÌiÃÊvÊÌÃiÊÜÊ>ÕÌÀ]ÊÀiÛiÜ]Êi`ÌÊ>`Ê>««ÀÛiÊ a study report ;

ÊUÊ iÝ«>Ê>>}iiÌ½ÃÊÀiÊÊ}iiÀ>ÌÊ>`ÊÃÃÕiÊvÊÀi«ÀÌÃÊÆ

ÊUÊ >À}ÕiÊ vÀÊ ÌiÊ iViÃÃÌÞÊ vÊ >V>Ì}Ê Õ>Ê >`Ê «ÞÃV>Ê ÀiÃÕÀViÃÊ ÌÊ >ÀVÛ}Ê activities ;

ÊUÊ `ÃÌ}ÕÃÊLiÌÜiiÊ>ÀVÛ}Ê>`ÊÃÌÀ>}iÊÊ>ÊVi`ÊÉÊÊvÀi«ÀvÊV>LiÌÊÆ ÊUÊ iÝ«>Ê>>}iiÌ½ÃÊÀiÊÊiÃÕÀ}ÊÌiÊÌi}ÀÌÞÊvÊÃÌÕ`ÞÊ`VÕiÌ>Ì°

(91)

85

(92)

86

Session 3:4:3

Session 3:4:4

(93)

87

(94)

88

Session 3:4:7

Session 3:4:8

(95)

89

(96)

90

Session 3:4:11

Session 3:4:12

(97)

91

Session 3:4:13

Questions

ÊUÊ 7ÞÊÃÊÌÊiViÃÃ>ÀÞÊÌÊ>ÛiÊ>Ê«ÀVi`ÕÀiÊvÀÊ«ÀÌiVÌ}ÊÃÌÕ`ÞÊ`VÕiÌ>ÌÊ¶Ê ÊUÊ 7iÀiÊÃÕ`ÊÃÌÕ`ÞÊ>ÌiÀ>ÃÊ`>Ì>]ÊÃ>«iÃ]ÊÃ«iViÃÊiÌV°®ÊLiÊÃÌÀi`Ê`ÕÀ}ÊÌiÊ

practical activities ; during writing / editing of the report ; after the report has been issued ?

ÊUÊ 7>ÌÊÃÊ>>}iiÌ½ÃÊÀiÊÊÌiÊ}iiÀ>ÌÊ>`Ê>>}iiÌÊvÊÃÌÕ`ÞÊ`VÕiÌ>ÌÊ¶

ÊUÊ ÜÊÃÊ>vÌiÀÊV«iÌÊvÊÌiÊ«À>VÌV>Ê>VÌÛÌiÃÊÃÕ`ÊÌiÊÀi«ÀÌÊLiÊÜÀÌÌiÊ¶

ÊUÊ ÜÊ`ÊÃÌÕ`ÞÊÀi«ÀÌÃÊÀi>ÌiÊÌÊÌiÊ«ÀÌVÊ¶Ê ÊUÊ ÜÊ`ÊÃÌÕ`ÞÊÀi«ÀÌÃÊÀi>ÌiÊÌÊÀ>ÜÊ`>Ì>Ê¶

ÊUÊ 7>ÌÊ>ÀiÊÌiÊ>ÊÃiVÌÃÊvÊÌiÊÃÌÕ`ÞÊÀi«ÀÌÊ¶

ÊUÊ 7ÊÃÕ`ÊÀiÛiÜÊÌiÊÀi«ÀÌÊLivÀiÊ>««ÀÛ>Ê>`ÊÃÃÕiÊ¶

ÊUÊ 7>ÌÊ`iÃÊÌiÊÀiÛiÜiÀ½ÃÊ>VÌÛÌÞÊ>VÌÕ>ÞÊi>ÊÊÌiÀÃÊvÊÜ>ÌÊÌiÞÊ>ÛiÊÀiÛiÜi`Ê or checked ? What does their signature signify ?

ÊUÊ 7ÊÃÊÀiÃ«ÃLiÊvÀÊÌiÊV«iÌiiÃÃÊvÊÌiÊÃÌÕ`ÞÊviÊ¶Ê

(98)

92

ÊUÊ 7>ÌÊ>ÀiÊÌiÊV>À>VÌiÀÃÌVÃÊvÊ>ÊÜi>>}i`Ê>ÀVÛiÊÃÞÃÌiÊ¶ÊÜÊ>ÀiÊÌiÃiÊ`v- ferent from the characteristics of the fireproof cabinet ?

ÊUÊ 7>ÌÊ ÃÀÌÊ vÊ `VÕiÌ>ÌÊ ÃÕ`Ê >Ê >ÀVÛÃÌÊ ii«Ê ÌÊ ÃÜÊ Ì>ÌÊ ÌiÊ >ÀVÛiÊ ÃÊ properly managed ?

ÊUÊ iÃ`iÃÊÃÌÕ`ÞÊ`VÕiÌ>Ì]ÊÜ>ÌÊÌiÀÊ`VÕiÌ>ÌÊ}ÌÊ>Ê>ÀVÛiÊVÌ>Ê¶

ÊUÊ ÜÊ`iÃÊÞÕÀÊv>VÌÞÊ>««À>VÊÌiÊii`ÊvÀÊ>ÀVÛ}ÊiiVÌÀVÊ`>Ì>Ê¶

ÊUÊ ÀÊÜÊ}ÊÃÕ`ÊÃÌÕ`ÞÊ`VÕiÌ>ÌÊLiÊi«ÌÊ¶Ê7>ÌÊ>LÕÌÊÃ«iViÃ]ÊÃ>«iÃ]Ê test item(s) ?

ÊUÊ -Õ`ÊÌÊLiÊ«ÃÃLiÊÌÊÀiÛiÊ>ÌiÀ>ÃÊvÀÊÌiÊ>ÀVÛiÊ¶

Workshops

1. Describe the ideal writing, review, editing and approval process for scientific reports produced in an imaginary research facility. Use the flip chart to tabulate authors and reviewers according to job title, activity, responsibility, meaning of signature.

2. Design a form for transferring materials to the archive.

3. Draw up a flow chart to describe the handover of documentation and material from the laboratory to the archive, showing when (during / after the study) this would be done.

4. List the SOPs necessary to ensure effective management of the archive.

5. List the records required to document that the archive is kept under control during the whole lifetime of the stored documents.

6. How is it possible to prevent the archive from becoming a repository for unwanted materials ? Discuss how to keep the archive functional and how to remove obsolete materials. Tabulate the persons who would give permission for removal / destruction of material in the archive.

(99)

93

SESSION 4

4.1 SUPERVISION AND QUALITY ASSURANCE

Goals

ÊUÊ >À}ÕiÊvÀÊÌiÊVÌÀLÕÌÊÌ>ÌÊ`vviÀiÌÊÃÕ«iÀÛÃÀÞÊ>`ÊÀiÛiÜÊÀiÃÊLÀ}ÊÌÊÌiÊ quality of the research activities and results ;

ÊUÊ iÝ«>ÊÌiÊiViÃÃÌÞÊvÀÊvÀ>â}ÊLÌÊÃViÌvVÊ>`Ê«ÀViÃÃÊ+®ÊÀiÛiÜÊÆ ÊUÊ iÝ«>Ê ÌiÊ Ài>ÌÃ«Ê LiÌÜiiÊ ÌiÊ `VÕiÌ>ÌÊ Ê ÃiVÌÊ ÎÊ 6Ã]Ê ÌÀ>}Ê

records) and supervision / QA ; ÊUÊ >iÊ>Ê«>ÊvÀÊ>Ê`iÊÀiÛiÜÊÆ

ÊUÊ ÃÕ}}iÃÌÊ«ÀÛiiÌÃÊÊÃÕ«iÀÛÃÊ>ÌÊÞÕÀÊÜÊÃÌÌÕÌÊvÊiViÃÃ>ÀÞ®ÊÆ

ÊUÊ Ài>`ÊÌiÊÃViÌvVÊÌiÀ>ÌÕÀiÊ>`Ê>>ÞÃiÊÌiÊÀi«ÀÌÃÊvÊÃViÌvVÊÃÌÕ`iÃÊÊÌiÀÃÊvÊ science and process.

Session 4:1:1

(100)

94

Session 4:1:2

Session 4:1:3

(101)

95

(102)

96

Session 4:1:6

Session 4:1:7

(103)

97

(104)

98

Session 4:1:10

Session 4:1:11

(105)

99

(106)

100

Session 4:1:14

Session 4:1:15

(107)

101

QUALITY PRACTICES

TRAINING MANUAL

Q uality practices

in basic biomedical research (Qpbr)

TRAINEE

QUALITY PRACTICES

IN BASIC BIOMEDICAL RESEARCH (QPBR) TRAINING MANUAL

FOR THE TRAINEE

A tool for training and promoting

Quality Practices in Basic Biomedical Research (QPBR)

concepts in disease endemic countries

FOREWORD

INTRODUCTION

How to use the WHO / TDR material

1.1 QUALITY PRACTICES IN BASIC BIOMEDICAL RESEARCH

1.2 WHAT IS QUALITY IN RESEARCH ?

SESSION 2

2.1 ORGANIZATION

2.2 PHYSICAL RESOURCES

3.1 DOCUMENTATION – OVERVIEW

3.2 PRESCRIPTIVE DOCUMENTATION

3.3 DESCRIPTIVE DOCUMENTATION – RAW DATA AND RECORDS

3.4 DOCUMENTATION – REPORTS AND STORAGE

SESSION 4

4.1 SUPERVISION AND QUALITY ASSURANCE

Q ^uality ^practices