TRAINEE - World Health Organization

More documents

Recommendations

Info

5. DOCUMENTATION RAW DATA AND DATA COLLECTION This section relates to the collection of experimental data. Carrying out the Procedures and Making the Observations Before the procedure is conducted, the study director will have ensured that: – Sufficient numbers of adequately trained and experienced staff are available. – Staff have read and understood the protocol and a copy is present where the procedure is to be carried out. – SOPs are written and are available in the work areas. If SOPs are not available for any reason (e.g. a non-standard method is to be used) this should be documented in the protocol or other study records and be available to staff following it. – Necessary equipment and supplies are available. – Data recording forms are in the work area. Before starting any procedure using equipment of any kind, the operator should ensure that it is functioning correctly and has undergone the required checks before use. In the case of a balance, this may involve use of check weights before every sequence of weighing, but at many laboratories the balance check is done less frequently unless the machine is moved. The operator should ensure that this has been done by reference to the appropriate log book or an equipment label. In summary, the important factors which are involved in making these observations are: – Adequate numbers of well-trained staff. – Appropriate equipment. – Good preparation with planning records available. – Complete instructions. 97
98 <strong>TRAINEE</strong>S Chapter 5 • GLP Training Manual Records and Recording Making a record is critical to complete reconstruction of the study. It is the only way of demonstrating what actually went on at the time and so must not only contain the data generated, but also prove that all the required procedures were correctly carried out at the correct time. Consequently, if the data are lost or a complete record is not made, experimental data are lost. Raw data are defined as original recordings made during the course of the study. These data are necessary for the “reconstruction” of the study, for example by an inspector, after the study completion date. The data should therefore indicate: – “WHAT was done” Describing what was done and demonstrating that the items laid down in the protocol were carried out and the SOPs were followed and, of course, including the results of the observation or measurement. – “HOW it was done” The data should indicate that they were collected and recorded in accordance with the methods set out in the SOPs and protocol, or indicate where these were deviations from the instructions. – “WHEN the work was performed” Demonstration that the timings laid down in the protocol were followed. This should be done by recording the date, and, if necessary, the time. For certain procedures very exact timing is necessary and the data must demonstrate that the schedule has been followed. Examples of this may be procedures required at definite times after dosing as in the case of toxicokinetic studies. – “WHO performed the work” The data should clearly identify who was responsible for carrying out the procedure and recording the data. Where more than one person is involved in a procedure this should be recorded in the data and the responsibilities of each detailed. The records retained are therefore a great deal more than a list of figures. All data generated during the conduct of a study should be identified and recorded directly, promptly, accurately, legibly and indelibly by the person entering the data, and be signed or initialled, and dated. Any changes should be made so as not to obscure the previous entry, and if necessary should indicate the reason for such change. Such changes should be identified by date and signature of the person making the change.
Page 2 and 3:
TDR/PRD/GLP/01.1B This document is
Page 4:
UNDP/World Bank/WHO Special Program
Page 8 and 9:
ABOUT THIS TRAINING MANUAL . . . .
Page 10 and 11:
ABOUT THIS TRAINING MANUAL This man
Page 12 and 13:
1. INTRODUCTION TO THE OECD PRINCIP
Page 14 and 15:
Chapter 1 • GLP Training Manual T
Page 16 and 17:
1. Introduction to the OECD Princip
Page 18 and 19:
Page 20 and 21:
Page 22 and 23:
Page 24 and 25:
Page 26 and 27:
Page 28 and 29:
Page 30 and 31:
PERSONNEL 2. RESOURCES Laboratory m
Page 32 and 33:
Page 34 and 35:
Page 36 and 37:
Page 38 and 39:
Page 40 and 41:
2. Resources 31
Page 42 and 43:
2. Resources 33
Page 44 and 45:
2. Resources 35
Page 46 and 47:
2. Resources 37
Page 48 and 49:
2. Resources 39
Page 50 and 51:
2. Resources 41
Page 52 and 53:
2. Resources 43
Page 54 and 55:
2. Resources 45
Page 56 and 57: 2. Resources 47
Page 58 and 59: 2. Resources 49
Page 60 and 61: 3. RULES THE PROTOCOL OR STUDY PLAN
Page 62 and 63: Chapter 3 • GLP Training Manual T
Page 68 and 69: 3. Rules 59
Page 84 and 85: THE TEST ITEM 4. CHARACTERIZATION T
Page 98 and 99: 4. Characterization 89
Page 114 and 115: 5. Documentation 105
Page 126 and 127: 6. QUALITY ASSURANCE UNIT QUALITY A
Page 132 and 133: 6. Quality Assurance Unit 123
Page 140 and 141: 7. WORKSHOPS - STUDY PLANS / PROTOC
Page 142 and 143: 8. WORKSHOP - STANDARD OPERATING PR
Page 146 and 147: 9. SELF ASSESSMENT QUESTIONNAIRE Wh
show all

TRAINEE - World Health Organization

Create successful ePaper yourself

Delete template?

Save as template?