ABPI:1988, amended 1990;:@0.083497:0.064712:0.265208:0.064712:0.265208:0.053809:0.083497:0.053809:0.011766:0.010944:0.009065:0.005386:0.004486:0.008087:0.008087:0.008087:0.008087:0.004083:0.004657:0.007187:0.012667:0.007187:0.008165:0.008165:0.007265:0.008165:0.005883:0.007435:0.007513:0.007513:0.007513:0.004315
NHS Indemnity:@0.796895:0.064848:0.894428:0.064848:0.894428:0.053359:0.796895:0.053359:0.010212:0.011111:0.007680:0.002369:0.005637:0.008170:0.008333:0.007255:0.012026:0.008170:0.004542:0.004771:0.007255
Research Involving Patients,:@0.082353:0.098182:0.269853:0.098182:0.269853:0.086692:0.082353:0.086692:0.009984:0.007255:0.006356:0.007255:0.008366:0.006356:0.007255:0.008366:0.004085:0.005441:0.008529:0.007255:0.008431:0.004542:0.007549:0.004542:0.008366:0.008333:0.003105:0.009722:0.007925:0.004542:0.004281:0.007255:0.007778:0.004542:0.005997:0.004085
 Royal College of Physicians of London: :@0.269771:0.098182:0.540654:0.098182:0.540654:0.086705:0.269771:0.086705:0.005882:0.010703:0.008170:0.008170:0.007255:0.004542:0.005114:0.010621:0.007925:0.004542:0.004281:0.007026:0.007925:0.007255:0.004510:0.008987:0.005964:0.002369:0.009085:0.008170:0.008399:0.006356:0.004542:0.007255:0.004542:0.007255:0.008170:0.006356:0.004379:0.008905:0.005964:0.002369:0.009641:0.007925:0.007925:0.007925:0.007925:0.007925:0.004542:0.004085
1990;:@0.085458:0.116047:0.120310:0.116047:0.120310:0.104569:0.085458:0.104569:0.007516:0.007598:0.007598:0.007598:0.004542
Guidelines in the Practice of Ethics Committees in Medical Research,:@0.086681:0.145467:0.540848:0.145467:0.540848:0.133977:0.086681:0.133977:0.011797:0.008170:0.004542:0.008007:0.007255:0.004346:0.004542:0.008170:0.007059:0.006356:0.003856:0.004330:0.007843:0.004657:0.004542:0.007958:0.007255:0.003775:0.009984:0.006356:0.008170:0.007255:0.004542:0.004542:0.007255:0.007255:0.004690:0.008170:0.004739:0.002778:0.009984:0.004804:0.008170:0.004739:0.007435:0.006356:0.004755:0.010899:0.008170:0.011797:0.011536:0.004542:0.004363:0.004542:0.007255:0.007075:0.006356:0.004265:0.004248:0.007516:0.004739:0.013611:0.007255:0.008170:0.004788:0.007255:0.008350:0.004542:0.002892:0.009804:0.007255:0.006062:0.007255:0.007859:0.006127:0.007255:0.007859:0.004085
 :@0.540766:0.145467:0.544851:0.145467:0.544851:0.133990:0.540766:0.133990:0.004085
2nd edition; Royal College of Physicians of London:  1990;:@0.083495:0.163016:0.469002:0.163016:0.469002:0.151539:0.083495:0.151539:0.008170:0.008170:0.008415:0.004085:0.007026:0.008170:0.004248:0.004542:0.004363:0.008170:0.007843:0.004542:0.004608:0.010703:0.008170:0.008170:0.007255:0.004542:0.005114:0.010621:0.007925:0.004542:0.004281:0.007026:0.007925:0.007255:0.004510:0.009232:0.006127:0.002288:0.009085:0.008170:0.008170:0.006356:0.004542:0.007255:0.004542:0.007255:0.008170:0.006356:0.004281:0.008905:0.005964:0.002778:0.009641:0.007925:0.008007:0.008170:0.007843:0.008007:0.004542:0.004085:0.002892:0.007435:0.007516:0.007516:0.007516:0.004542
Clinical Trial Compensation Guidelines:@0.085864:0.195783:0.348266:0.195783:0.348266:0.184293:0.085864:0.184293:0.010899:0.004379:0.004542:0.008170:0.004542:0.007255:0.008170:0.004542:0.004771:0.008824:0.006356:0.004265:0.007925:0.004542:0.004526:0.010899:0.007974:0.011797:0.007974:0.007255:0.008170:0.006062:0.008170:0.004542:0.004363:0.008170:0.008007:0.005065:0.011797:0.008170:0.004542:0.008007:0.007255:0.004346:0.004542:0.008170:0.007059:0.006356
 ABPI:  1991:@0.348201:0.195783:0.429900:0.195783:0.429900:0.184306:0.348201:0.184306:0.004330:0.011356:0.010621:0.008742:0.005441:0.004281:0.004085:0.002941:0.007190:0.007271:0.007271:0.008170
3. :@0.083497:0.242437:0.099020:0.242437:0.099020:0.230960:0.083497:0.230960:0.007598:0.003840:0.004085
The Medicines Act 1968 provides the regulatory framework for clinical studies involving :@0.130556:0.242437:0.718219:0.242437:0.718219:0.230960:0.130556:0.230960:0.009722:0.007925:0.007255:0.004085:0.014526:0.007255:0.008170:0.004379:0.007255:0.004542:0.008170:0.007255:0.006356:0.004739:0.011797:0.007255:0.004542:0.005408:0.007598:0.007598:0.007680:0.007680:0.004330:0.008170:0.005441:0.007958:0.008170:0.004542:0.008170:0.007255:0.006356:0.003905:0.004542:0.007958:0.007255:0.004592:0.005441:0.007255:0.007974:0.008170:0.004542:0.007255:0.004542:0.007925:0.005441:0.008170:0.004281:0.005441:0.005441:0.007255:0.012712:0.007255:0.011797:0.008170:0.005441:0.008170:0.004085:0.005441:0.008415:0.005637:0.003922:0.007255:0.004346:0.004542:0.008170:0.004281:0.007255:0.007255:0.004363:0.005065:0.006127:0.004542:0.007876:0.008007:0.004542:0.007059:0.006356:0.004510:0.004542:0.008170:0.008170:0.007958:0.004542:0.007958:0.004542:0.008170:0.007958:0.004085
administration of drugs to patients. Drugs which are used in a sponsored* clinical study in :@0.130554:0.260302:0.723691:0.260302:0.723691:0.248824:0.130554:0.248824:0.007255:0.008350:0.012712:0.004542:0.008170:0.004542:0.006356:0.004542:0.005441:0.007255:0.004542:0.004542:0.008170:0.008170:0.003448:0.008987:0.005964:0.002696:0.008170:0.005441:0.008170:0.008170:0.006160:0.003922:0.004542:0.008170:0.004085:0.008170:0.006977:0.004542:0.004363:0.007255:0.007859:0.004542:0.006078:0.004085:0.004984:0.011797:0.005441:0.008170:0.008170:0.006356:0.004428:0.011797:0.008170:0.004788:0.007255:0.008350:0.003513:0.007255:0.005163:0.007255:0.004265:0.008170:0.006356:0.007451:0.008170:0.004412:0.004542:0.008366:0.003922:0.007435:0.004085:0.006127:0.008007:0.008007:0.008007:0.006356:0.007859:0.005441:0.006977:0.008007:0.008007:0.005065:0.007255:0.004346:0.004542:0.008170:0.004542:0.007255:0.007255:0.004542:0.004706:0.006356:0.004346:0.007925:0.007925:0.007925:0.004739:0.004542:0.008366:0.004085
patients will be the subject of either a product licence (PL), a clinical trial certificate (CTC), or :@0.130227:0.278168:0.753397:0.278168:0.753397:0.266691:0.130227:0.266691:0.008170:0.007255:0.004265:0.004542:0.007255:0.008170:0.004542:0.006356:0.004346:0.011797:0.004542:0.004542:0.004542:0.003170:0.008333:0.007255:0.004428:0.004542:0.007958:0.007255:0.004918:0.006356:0.008170:0.008170:0.004542:0.007255:0.007255:0.004542:0.004085:0.008775:0.005964:0.002778:0.007255:0.004542:0.004542:0.008333:0.007255:0.005654:0.003595:0.007435:0.003513:0.008333:0.005441:0.008366:0.008170:0.008170:0.007435:0.004542:0.004085:0.004363:0.004542:0.007059:0.007255:0.007941:0.007255:0.007042:0.005065:0.005229:0.008660:0.009559:0.005229:0.004085:0.004902:0.007435:0.003922:0.007255:0.004346:0.004542:0.008170:0.004281:0.007255:0.007255:0.004363:0.004739:0.004542:0.005441:0.004542:0.007255:0.004542:0.004085:0.007418:0.007255:0.005441:0.004542:0.004330:0.005441:0.004363:0.007255:0.007255:0.004363:0.007255:0.005082:0.005441:0.010408:0.009722:0.010621:0.005229:0.004085:0.005065:0.008170:0.005441:0.004085
clinical trial exemption (CTh) which is held by the company as appropriate. A non-sponsored :@0.130554:0.296034:0.745554:0.296034:0.745554:0.284557:0.130554:0.284557:0.007255:0.004346:0.004542:0.008170:0.004281:0.007255:0.007255:0.004363:0.003922:0.004542:0.005441:0.004542:0.007255:0.004542:0.004314:0.007255:0.008350:0.007255:0.012925:0.008170:0.004739:0.004542:0.008170:0.008366:0.003513:0.005441:0.010572:0.009804:0.008007:0.005441:0.004281:0.011797:0.008170:0.004788:0.007255:0.008350:0.003595:0.004542:0.005997:0.004739:0.008170:0.007255:0.004542:0.008170:0.003235:0.008415:0.008415:0.003922:0.004542:0.007958:0.007255:0.004592:0.007255:0.008170:0.012712:0.007974:0.007255:0.008170:0.008170:0.004592:0.006863:0.006046:0.004330:0.007255:0.008170:0.007859:0.005441:0.007876:0.008007:0.005441:0.004542:0.007010:0.004542:0.007255:0.003889:0.005474:0.011797:0.003889:0.008170:0.008333:0.008170:0.005441:0.006356:0.008170:0.008170:0.008170:0.006356:0.008170:0.005441:0.007255:0.008170:0.004085
study conducted independently by a practitioner must be notified to the Licensing Authority :@0.130962:0.313962:0.734639:0.313962:0.734639:0.302485:0.130962:0.302485:0.006046:0.004330:0.007925:0.007925:0.007925:0.004657:0.007255:0.008170:0.008170:0.008170:0.008170:0.007255:0.004542:0.007255:0.008170:0.003431:0.004542:0.008170:0.008170:0.007255:0.008170:0.007255:0.008170:0.008170:0.007255:0.008170:0.004542:0.004542:0.008170:0.003905:0.008170:0.008170:0.004820:0.007516:0.003513:0.008170:0.005637:0.007255:0.007255:0.004542:0.004542:0.004542:0.004542:0.008170:0.008170:0.007255:0.005441:0.004085:0.012712:0.007925:0.006356:0.004346:0.003513:0.008333:0.007255:0.004837:0.008170:0.008007:0.004542:0.004542:0.005441:0.004542:0.007255:0.008170:0.003824:0.004330:0.007843:0.004330:0.004542:0.007958:0.007255:0.004510:0.009984:0.004722:0.007255:0.007255:0.008170:0.006356:0.004542:0.008170:0.008170:0.004412:0.011520:0.008170:0.004330:0.008007:0.008007:0.005441:0.004363:0.004542:0.007958:0.004085
under the Doctors and Dentists Exemption (DDX) scheme. Studies in healthy volunteers are not :@0.130227:0.331828:0.759345:0.331828:0.759345:0.320351:0.130227:0.320351:0.008170:0.008170:0.008170:0.007516:0.005441:0.003301:0.004542:0.007958:0.007255:0.004085:0.011797:0.008170:0.007255:0.004542:0.008170:0.005180:0.006356:0.004265:0.007255:0.008170:0.008170:0.003448:0.011797:0.007255:0.008170:0.004722:0.004542:0.006356:0.004542:0.006356:0.004085:0.009984:0.008170:0.007255:0.013007:0.008170:0.004542:0.004771:0.008170:0.008333:0.003513:0.005441:0.011552:0.011520:0.011601:0.005441:0.005016:0.006356:0.006797:0.007843:0.006863:0.012255:0.006944:0.003922:0.006291:0.008824:0.004542:0.007794:0.007925:0.004330:0.007026:0.006356:0.004085:0.004918:0.008497:0.003186:0.008007:0.007255:0.007255:0.004281:0.004542:0.008170:0.007958:0.003922:0.008170:0.008333:0.004542:0.008170:0.008170:0.004542:0.007255:0.007255:0.005441:0.006356:0.004314:0.007255:0.005163:0.007255:0.004085:0.008170:0.008170:0.004542:0.004085
subject to regulation under the Medicines Act and do not require a CTC, Cm, or DDX. Further :@0.130962:0.349694:0.752172:0.349694:0.752172:0.338217:0.130962:0.338217:0.006356:0.008170:0.007941:0.004542:0.007255:0.007075:0.004542:0.003546:0.004330:0.007843:0.005065:0.005441:0.007255:0.008170:0.008170:0.004542:0.007255:0.004542:0.004542:0.008170:0.008170:0.003595:0.008333:0.008170:0.008497:0.007435:0.005441:0.003301:0.004542:0.007958:0.007255:0.004510:0.014526:0.007255:0.007958:0.004542:0.007255:0.004542:0.008170:0.006944:0.006356:0.004592:0.011797:0.007255:0.004542:0.003856:0.007435:0.008170:0.008333:0.003922:0.007843:0.007843:0.005147:0.008170:0.008007:0.004542:0.004085:0.005441:0.006928:0.008007:0.008170:0.004330:0.005441:0.007059:0.004657:0.007516:0.004248:0.010458:0.009722:0.010458:0.003922:0.005474:0.010131:0.011928:0.003840:0.005065:0.008497:0.005637:0.003513:0.011356:0.011438:0.011356:0.004085:0.004902:0.009085:0.008170:0.005621:0.004542:0.008170:0.007467:0.005441:0.004085
particulars of these arrangements are provided in Medicines Act leaflet :@0.130227:0.367559:0.598119:0.367559:0.598119:0.356082:0.130227:0.356082:0.008170:0.007255:0.005163:0.004542:0.004542:0.007255:0.008170:0.004542:0.007255:0.005441:0.006356:0.004085:0.009085:0.005964:0.002369:0.004542:0.008170:0.007255:0.006176:0.007255:0.004592:0.007255:0.005245:0.005441:0.007255:0.008170:0.008170:0.007255:0.012712:0.007255:0.008170:0.004542:0.006356:0.004330:0.006944:0.005229:0.007026:0.004330:0.008333:0.005441:0.008366:0.008170:0.004542:0.008366:0.007255:0.008350:0.003922:0.004820:0.008497:0.003186:0.014526:0.007042:0.008170:0.004542:0.007255:0.004542:0.008170:0.007255:0.006356:0.004281:0.011797:0.007255:0.004542:0.003856:0.004542:0.007255:0.007255:0.005703:0.004542:0.007255:0.004542:0.004085
M}U 30: A guide to the:@0.597204:0.367559:0.754459:0.367559:0.754459:0.356069:0.597204:0.356069:0.015359:0.005882:0.014052:0.005556:0.007680:0.007598:0.005065:0.003513:0.010621:0.004330:0.008333:0.008170:0.004739:0.008170:0.007435:0.004739:0.004248:0.007516:0.005065:0.004248:0.007680:0.007255
 :@0.754067:0.367559:0.758152:0.367559:0.758152:0.356082:0.754067:0.356082:0.004085
provisions affecting doctors and dentists (DHSS: 1985).:@0.128593:0.385172:0.494034:0.385172:0.494034:0.373682:0.128593:0.373682:0.008170:0.006699:0.008415:0.007435:0.004542:0.006569:0.004542:0.008529:0.008415:0.006536:0.003922:0.008170:0.004542:0.004542:0.007255:0.007516:0.004542:0.004542:0.008170:0.008170:0.004085:0.008170:0.008170:0.007255:0.004542:0.008170:0.006356:0.006356:0.003905:0.008497:0.008497:0.008497:0.003186:0.008170:0.007255:0.008170:0.004346:0.004542:0.006356:0.004542:0.006356:0.005163:0.005147:0.011111:0.011193:0.007761:0.007761:0.005229:0.006291:0.007435:0.007516:0.007516:0.007516:0.005065:0.004085
4. :@0.083497:0.421225:0.099020:0.421225:0.099020:0.409747:0.083497:0.409747:0.007598:0.003840:0.004085
Participants in a clinical study may suffer adverse effects due to the drug or clinical procedures. :@0.130147:0.421225:0.757435:0.421225:0.757435:0.409747:0.130147:0.409747:0.009085:0.007255:0.005229:0.004542:0.004542:0.007255:0.004542:0.008170:0.007255:0.008170:0.004542:0.006356:0.004085:0.004918:0.008497:0.003595:0.007435:0.004085:0.007026:0.004542:0.004542:0.008170:0.004542:0.007042:0.007255:0.004542:0.004706:0.006356:0.004346:0.007925:0.007925:0.007925:0.004739:0.012418:0.007026:0.008170:0.004902:0.006356:0.008170:0.005441:0.005441:0.007255:0.005441:0.003480:0.007255:0.008170:0.008170:0.007042:0.005441:0.006160:0.007255:0.004673:0.007255:0.005163:0.005441:0.007059:0.007255:0.004265:0.006356:0.004592:0.008170:0.007925:0.007255:0.004085:0.004542:0.008170:0.004085:0.004542:0.008170:0.007026:0.004657:0.008170:0.005441:0.008170:0.008170:0.003791:0.008497:0.005637:0.003922:0.007255:0.004346:0.004542:0.008170:0.004281:0.007255:0.007255:0.004363:0.003922:0.008007:0.005441:0.007958:0.007255:0.007042:0.008007:0.008007:0.005441:0.007255:0.006095:0.004085:0.004085
The appendix to this annex is a model form of agreement between the company sponsoring a :@0.130554:0.438774:0.741338:0.438774:0.741338:0.427297:0.130554:0.427297:0.009722:0.007925:0.007255:0.004510:0.007255:0.008350:0.008170:0.007255:0.008170:0.008170:0.004542:0.008170:0.003480:0.004330:0.007843:0.004657:0.004542:0.007958:0.004542:0.006160:0.004657:0.007255:0.008350:0.008170:0.007255:0.008170:0.004085:0.004101:0.005964:0.004739:0.007435:0.004330:0.012418:0.008007:0.008007:0.007026:0.004542:0.003873:0.005441:0.008529:0.005441:0.013186:0.003513:0.008905:0.005964:0.002778:0.007255:0.008350:0.005441:0.007255:0.007255:0.012712:0.007255:0.008170:0.004542:0.003088:0.008415:0.007516:0.004542:0.012124:0.007435:0.007255:0.008431:0.003105:0.004542:0.008170:0.007255:0.004788:0.007255:0.008170:0.012353:0.008170:0.007255:0.007941:0.008170:0.004984:0.006356:0.008170:0.007941:0.008170:0.006356:0.008170:0.005441:0.004542:0.008170:0.008170:0.003840:0.007026:0.004085
study and the NHS body involved, which indemnifies the authority or trust against claims and :@0.130962:0.456955:0.747792:0.456955:0.747792:0.445477:0.130962:0.445477:0.006046:0.004330:0.007925:0.007925:0.007925:0.004657:0.007255:0.008170:0.008170:0.003529:0.004542:0.007958:0.007255:0.003775:0.011797:0.011977:0.009085:0.004085:0.008170:0.008170:0.008170:0.008170:0.004477:0.004542:0.008170:0.008170:0.007958:0.004542:0.008170:0.007059:0.008170:0.004085:0.004575:0.011797:0.008382:0.004542:0.007467:0.008170:0.003595:0.004542:0.008170:0.007958:0.007255:0.012712:0.008170:0.004542:0.005441:0.004542:0.007255:0.006356:0.004265:0.004542:0.007958:0.007255:0.004510:0.007255:0.008170:0.004542:0.007974:0.008170:0.005441:0.004363:0.004542:0.007958:0.004330:0.008497:0.005637:0.003513:0.004542:0.005441:0.008170:0.006356:0.004542:0.004281:0.007255:0.008170:0.007042:0.004542:0.008170:0.006160:0.004542:0.004363:0.007255:0.004542:0.007075:0.004542:0.012712:0.006193:0.004739:0.007255:0.007859:0.008170:0.004085
proceedings arising from the study. The model agreement has been drawn up in consultation :@0.130227:0.474819:0.738462:0.474819:0.738462:0.463342:0.130227:0.463342:0.008170:0.005441:0.008170:0.007255:0.007075:0.007255:0.008170:0.004346:0.008170:0.008170:0.006356:0.004510:0.007255:0.005441:0.004542:0.006356:0.004542:0.008170:0.008382:0.003595:0.005441:0.005441:0.008170:0.013056:0.003513:0.004542:0.007958:0.007255:0.005000:0.006127:0.004330:0.007761:0.007761:0.007761:0.004085:0.004902:0.009984:0.008170:0.007255:0.004820:0.012712:0.007958:0.008170:0.007026:0.004542:0.004281:0.007255:0.008170:0.005245:0.007255:0.007255:0.012451:0.007255:0.008170:0.004346:0.004739:0.007925:0.007026:0.006356:0.003775:0.008497:0.007598:0.007598:0.008497:0.003513:0.008170:0.005441:0.007255:0.012059:0.008170:0.003186:0.008007:0.008170:0.004248:0.004902:0.008824:0.003513:0.007255:0.008170:0.008170:0.006356:0.008170:0.004542:0.004542:0.007255:0.004542:0.004542:0.008170:0.008170:0.004085
with the Association of the British Pharmaceutical Industry:@0.130227:0.492433:0.516992:0.492433:0.516992:0.480956:0.130227:0.480956:0.012092:0.004542:0.004771:0.008170:0.003350:0.004542:0.007958:0.007255:0.004510:0.011797:0.006356:0.006356:0.008415:0.007255:0.004542:0.007255:0.004722:0.004542:0.008170:0.008170:0.003627:0.008905:0.005964:0.002369:0.004542:0.007958:0.007255:0.004085:0.011291:0.005441:0.004771:0.004542:0.004542:0.006683:0.008170:0.003268:0.009085:0.008170:0.007255:0.005441:0.012712:0.007255:0.007255:0.007255:0.008170:0.004542:0.004542:0.007255:0.007255:0.004542:0.004412:0.005441:0.007876:0.008007:0.008170:0.005964:0.004542:0.005261:0.008170
(ABPI).:@0.130964:0.507273:0.181830:0.507273:0.181830:0.495795:0.130964:0.495795:0.005441:0.011307:0.010539:0.008824:0.005229:0.005441:0.004085
5. :@0.083497:0.539091:0.099020:0.539091:0.099020:0.527614:0.083497:0.527614:0.007598:0.003840:0.004085
This form of indemnity will not normally apply to clinical studies which are not directly :@0.130556:0.539091:0.709559:0.539091:0.709559:0.527614:0.130556:0.527614:0.009804:0.008170:0.004542:0.006160:0.003922:0.005441:0.008448:0.005441:0.013186:0.003513:0.008987:0.005964:0.002696:0.004542:0.008170:0.008170:0.006977:0.012712:0.007958:0.004542:0.004363:0.008170:0.004657:0.011797:0.004542:0.004542:0.004542:0.004085:0.008170:0.008170:0.004722:0.003922:0.008170:0.008170:0.005441:0.012451:0.007255:0.004542:0.004297:0.008170:0.004085:0.007516:0.008170:0.008170:0.004542:0.008170:0.004363:0.004330:0.007843:0.004657:0.007255:0.004346:0.004542:0.008170:0.004542:0.007255:0.007255:0.004542:0.004706:0.006356:0.004346:0.008170:0.007843:0.004542:0.007255:0.006176:0.004330:0.011797:0.008170:0.004788:0.007255:0.008350:0.003513:0.007255:0.005163:0.007255:0.004673:0.008170:0.008007:0.004542:0.004085:0.007958:0.004542:0.005261:0.007255:0.006961:0.004542:0.004363:0.008007:0.004085
sponsored by the company providing the product for research, but have been independently :@0.130962:0.556641:0.730374:0.556641:0.730374:0.545164:0.130962:0.545164:0.006356:0.008170:0.007941:0.008170:0.006356:0.007941:0.005441:0.007059:0.008170:0.003431:0.008170:0.008333:0.004085:0.004330:0.008170:0.007255:0.004755:0.007255:0.008170:0.012353:0.008170:0.007255:0.007941:0.008170:0.004248:0.008170:0.005441:0.008170:0.008170:0.004542:0.008170:0.004722:0.008170:0.008170:0.003676:0.004542:0.007958:0.007255:0.004085:0.008350:0.005441:0.008366:0.008170:0.008170:0.007255:0.004542:0.003889:0.005441:0.008529:0.005637:0.004085:0.005229:0.007026:0.006356:0.006961:0.007255:0.005163:0.007255:0.007859:0.004085:0.004085:0.008578:0.008415:0.004739:0.004330:0.007925:0.007255:0.007859:0.007255:0.003775:0.008333:0.007516:0.007516:0.008415:0.003186:0.004542:0.008170:0.007958:0.007255:0.007941:0.007255:0.008170:0.008170:0.007255:0.008170:0.004542:0.004542:0.008170:0.004085
organised by clinicians. In this case, the NHS body will normally carry full legal liability for any :@0.130554:0.574254:0.758168:0.574254:0.758168:0.562777:0.130554:0.562777:0.008170:0.005441:0.008170:0.007255:0.007974:0.004542:0.006356:0.007255:0.007990:0.002778:0.008415:0.008415:0.003922:0.007255:0.004542:0.004379:0.008170:0.004248:0.007255:0.004346:0.007255:0.007859:0.006356:0.003856:0.005065:0.005637:0.008497:0.002778:0.004542:0.007958:0.004542:0.006078:0.004330:0.007026:0.007255:0.005980:0.007255:0.003856:0.004248:0.004542:0.007958:0.007255:0.003448:0.011797:0.011797:0.008922:0.003513:0.008170:0.008170:0.008333:0.008170:0.004085:0.011601:0.004542:0.004542:0.004542:0.003775:0.008170:0.008170:0.005441:0.012451:0.007255:0.004542:0.004297:0.008170:0.004248:0.007255:0.006961:0.005441:0.005261:0.008007:0.003922:0.005441:0.008170:0.004542:0.004542:0.004085:0.004346:0.007255:0.007941:0.007255:0.004542:0.003807:0.004542:0.004542:0.007255:0.008007:0.004542:0.004363:0.004542:0.004363:0.008170:0.003840:0.005441:0.008529:0.005637:0.003513:0.006944:0.007680:0.007680:0.004085
claims in negligence arising from harm to subjects in the study.:@0.130554:0.591487:0.542564:0.591487:0.542564:0.580010:0.130554:0.580010:0.007255:0.004265:0.007255:0.004542:0.012386:0.006356:0.004673:0.004542:0.008366:0.003513:0.008170:0.007255:0.008170:0.004346:0.004542:0.008170:0.007255:0.007974:0.007255:0.007042:0.004739:0.007255:0.005441:0.004542:0.006356:0.004542:0.008170:0.008382:0.003513:0.005441:0.005670:0.008415:0.013072:0.003513:0.008170:0.007516:0.005441:0.013023:0.003105:0.004542:0.008170:0.004935:0.006356:0.008170:0.007859:0.004542:0.006977:0.007255:0.004346:0.006356:0.004085:0.004918:0.008578:0.003105:0.004542:0.007958:0.007255:0.004918:0.006127:0.004248:0.007680:0.007680:0.007680:0.004085
6. :@0.083497:0.626970:0.099020:0.626970:0.099020:0.615492:0.083497:0.615492:0.007598:0.003840:0.004085
The NHS body will also carry full legal liability for any claims in negligence (or compensation :@0.130147:0.626970:0.754542:0.626970:0.754542:0.615492:0.130147:0.615492:0.009722:0.007925:0.007026:0.004330:0.011601:0.011601:0.008905:0.004330:0.008170:0.008170:0.008170:0.008170:0.004085:0.011797:0.004542:0.004542:0.004542:0.004477:0.007026:0.004330:0.006356:0.007778:0.005147:0.007255:0.006961:0.005441:0.005261:0.008170:0.004085:0.005441:0.008170:0.004542:0.004542:0.004085:0.004542:0.007255:0.008170:0.007255:0.004542:0.004281:0.004542:0.004542:0.007092:0.008170:0.004330:0.004542:0.004542:0.004314:0.008170:0.004248:0.005441:0.008529:0.005637:0.003922:0.007026:0.007843:0.007843:0.004739:0.007255:0.004542:0.007075:0.004542:0.012712:0.006193:0.004330:0.004820:0.008497:0.003513:0.008170:0.007255:0.008170:0.004542:0.004542:0.008007:0.007255:0.008170:0.006961:0.007255:0.005000:0.005441:0.008170:0.005441:0.003660:0.007255:0.008170:0.012516:0.008170:0.007255:0.008170:0.006356:0.007255:0.004542:0.004542:0.008170:0.008170:0.004085
under the indemnity will be abated) where there has been significant non-adherence to the agreed :@0.129820:0.644835:0.759395:0.644835:0.759395:0.633357:0.129820:0.633357:0.008170:0.008170:0.008415:0.007255:0.005654:0.002696:0.004542:0.007958:0.007255:0.003366:0.004542:0.008170:0.007958:0.007255:0.012712:0.008170:0.004542:0.004542:0.008170:0.003791:0.011601:0.004542:0.004542:0.004542:0.002631:0.008333:0.007255:0.004085:0.007255:0.007876:0.007255:0.004346:0.007255:0.007941:0.005441:0.003873:0.011601:0.008007:0.007255:0.005245:0.007255:0.003448:0.004542:0.008170:0.007059:0.005441:0.007255:0.004085:0.007974:0.007255:0.006356:0.002647:0.008415:0.007598:0.007598:0.008497:0.003186:0.006356:0.004542:0.007974:0.008170:0.004542:0.005261:0.004542:0.007059:0.007255:0.008170:0.004346:0.003513:0.008170:0.008170:0.008170:0.005441:0.007255:0.008170:0.008170:0.007255:0.005441:0.007255:0.008170:0.007255:0.007255:0.003415:0.004330:0.007843:0.003922:0.004542:0.007958:0.007255:0.003775:0.007255:0.008170:0.005441:0.007255:0.007255:0.008170:0.004085
protocol or there has been negligence on the part of an NHS employee, for example, by failing to :@0.129820:0.662699:0.758170:0.662699:0.758170:0.651222:0.129820:0.651222:0.008170:0.005441:0.008170:0.004542:0.008170:0.007255:0.008170:0.004542:0.003546:0.008497:0.005637:0.003105:0.004542:0.007958:0.007255:0.005245:0.007255:0.004265:0.007761:0.006944:0.006046:0.003513:0.008333:0.007516:0.007516:0.008415:0.003186:0.008170:0.007255:0.008170:0.004346:0.004542:0.008170:0.007255:0.007974:0.007255:0.007042:0.004330:0.008415:0.008415:0.002369:0.004542:0.008170:0.007255:0.003562:0.008415:0.007516:0.005441:0.004853:0.003186:0.008905:0.005964:0.002369:0.007598:0.008497:0.002369:0.011601:0.011601:0.008905:0.004330:0.007255:0.012353:0.008170:0.004542:0.007958:0.008170:0.007255:0.006961:0.004085:0.004248:0.005441:0.008529:0.005637:0.003105:0.007255:0.007941:0.007255:0.012353:0.008170:0.004330:0.007255:0.003856:0.003595:0.008415:0.008415:0.003513:0.005441:0.007255:0.004706:0.004542:0.004542:0.008399:0.008170:0.003268:0.004330:0.007761:0.004085
deal adequately with an adverse drug reaction.:@0.130229:0.680629:0.431536:0.680629:0.431536:0.669152:0.130229:0.669152:0.008170:0.007255:0.007255:0.004363:0.004085:0.007255:0.007941:0.007255:0.008170:0.007941:0.007255:0.004542:0.007075:0.004542:0.008170:0.004085:0.011797:0.004820:0.004542:0.008366:0.004085:0.007435:0.008497:0.003513:0.007255:0.008170:0.008170:0.007042:0.005441:0.006160:0.007255:0.004592:0.008170:0.005441:0.008170:0.008170:0.003791:0.005441:0.006895:0.007026:0.007026:0.004330:0.004542:0.007794:0.007925:0.004085
7. :@0.083905:0.716364:0.099020:0.716364:0.099020:0.704886:0.083905:0.704886:0.007353:0.003676:0.004085
The form of indemnity may not be readily accepted by sponsoring companies outside the UK or :@0.130147:0.716364:0.759363:0.716364:0.759363:0.704886:0.130147:0.704886:0.009722:0.007925:0.007026:0.004330:0.005441:0.008170:0.005441:0.013056:0.003595:0.008905:0.005964:0.002778:0.004542:0.008170:0.007958:0.007255:0.012435:0.008170:0.004330:0.004542:0.008170:0.004608:0.012418:0.007026:0.008170:0.004493:0.008170:0.008170:0.004542:0.003056:0.008333:0.007255:0.004428:0.005441:0.006977:0.007255:0.008170:0.004346:0.004542:0.007958:0.004330:0.007255:0.007451:0.007255:0.007255:0.008170:0.004542:0.007255:0.008170:0.003023:0.008415:0.008497:0.004657:0.006356:0.008170:0.007941:0.008170:0.006356:0.008170:0.005441:0.004542:0.008170:0.008170:0.003431:0.007255:0.008170:0.012712:0.008170:0.007255:0.008170:0.004542:0.007255:0.006356:0.004085:0.008170:0.008170:0.004542:0.006127:0.004542:0.008170:0.007059:0.003922:0.004542:0.008170:0.007255:0.004379:0.011797:0.012141:0.004085:0.008170:0.005441:0.004085
who are not members of the ABPI.  NHS bodies should, as part of their risk management, :@0.129820:0.734230:0.719085:0.734230:0.719085:0.722753:0.129820:0.722753:0.011438:0.008170:0.007843:0.004657:0.007255:0.005163:0.007255:0.004673:0.008170:0.008170:0.004542:0.004085:0.012712:0.007255:0.012500:0.008170:0.007255:0.005163:0.006356:0.004265:0.008905:0.005964:0.002369:0.004542:0.008170:0.007255:0.004706:0.011438:0.010703:0.008905:0.005441:0.004085:0.004085:0.004771:0.011601:0.011797:0.008791:0.003922:0.008170:0.008333:0.008170:0.004739:0.007255:0.006356:0.005180:0.006356:0.007778:0.007843:0.007843:0.004330:0.007843:0.003922:0.005065:0.006944:0.006046:0.004248:0.008333:0.007435:0.005441:0.004542:0.004085:0.008971:0.005964:0.002288:0.004739:0.008333:0.007255:0.004755:0.005441:0.004085:0.005441:0.004542:0.006356:0.008170:0.004085:0.012533:0.007026:0.008007:0.007255:0.007859:0.007255:0.012271:0.007255:0.007859:0.004542:0.004085:0.004085
consider the value of indemnities which are offered and consider whether companies should :@0.130229:0.752095:0.734641:0.752095:0.734641:0.740617:0.130229:0.740617:0.007255:0.008170:0.008170:0.006356:0.004363:0.008170:0.007255:0.005441:0.003644:0.004542:0.007958:0.007255:0.003775:0.008170:0.007255:0.004542:0.008170:0.007255:0.004559:0.009150:0.006127:0.002778:0.004542:0.008170:0.008170:0.006977:0.012712:0.008170:0.004363:0.004542:0.004542:0.007255:0.006356:0.004085:0.012026:0.008170:0.004739:0.007255:0.008350:0.003513:0.007255:0.005163:0.007255:0.004592:0.008170:0.005441:0.005441:0.007255:0.005441:0.007255:0.008170:0.004085:0.007255:0.008170:0.008170:0.004085:0.007255:0.008170:0.008170:0.006356:0.004542:0.008170:0.007484:0.005441:0.003546:0.011797:0.008382:0.007255:0.004542:0.008170:0.007255:0.005441:0.004085:0.007255:0.008170:0.012533:0.008170:0.007255:0.007941:0.004542:0.007255:0.006356:0.004559:0.006356:0.007941:0.008007:0.008007:0.004542:0.007876:0.004085
have alternative arrangements in place.:@0.130229:0.769960:0.383660:0.769960:0.383660:0.758482:0.130229:0.758482:0.007843:0.007026:0.007843:0.007026:0.004739:0.007255:0.004542:0.004542:0.007255:0.005163:0.008170:0.007255:0.004346:0.004542:0.007958:0.007255:0.004673:0.007255:0.005245:0.005441:0.007255:0.008170:0.008170:0.007255:0.012712:0.007255:0.008170:0.004542:0.006356:0.004330:0.004820:0.008497:0.003105:0.007925:0.004542:0.006814:0.007026:0.007026:0.004085
*A sponsored study may be defined as one carried out under arrangements made by or on behalf of the company who :@0.083905:0.861588:0.701474:0.861588:0.701474:0.852407:0.083905:0.852407:0.006536:0.009150:0.003516:0.004902:0.006536:0.006366:0.006536:0.005085:0.006353:0.004353:0.005621:0.006536:0.004248:0.005085:0.003634:0.006536:0.006536:0.006536:0.002222:0.010458:0.005804:0.006863:0.002771:0.006536:0.005804:0.003752:0.006536:0.005804:0.004170:0.003634:0.006536:0.005804:0.006327:0.003516:0.005634:0.005085:0.003268:0.006536:0.006536:0.005804:0.003569:0.005804:0.005634:0.004353:0.004353:0.003634:0.005804:0.006536:0.003503:0.006536:0.006706:0.003634:0.002327:0.006706:0.006536:0.006536:0.006039:0.004353:0.003569:0.005804:0.004353:0.004549:0.005804:0.006536:0.006536:0.005804:0.010170:0.005804:0.006536:0.003634:0.005085:0.002758:0.010170:0.005804:0.006732:0.005804:0.003268:0.006863:0.006863:0.002693:0.006536:0.004353:0.003268:0.006536:0.006353:0.003268:0.006784:0.006131:0.006941:0.006131:0.003843:0.004575:0.001961:0.007359:0.004824:0.001556:0.003634:0.006536:0.005804:0.003634:0.005804:0.006536:0.010170:0.006536:0.006000:0.006536:0.006536:0.002863:0.009229:0.006366:0.006536:0.003268
manufactured the product, the company responsible for its composition, or the company selling or supplying the product.:@0.083497:0.883369:0.715771:0.883369:0.715771:0.874187:0.083497:0.874187:0.010170:0.005804:0.006536:0.006536:0.004353:0.005804:0.005804:0.003634:0.006536:0.004353:0.005804:0.006536:0.003046:0.003634:0.006536:0.005804:0.003634:0.006536:0.004353:0.006261:0.006536:0.006209:0.005804:0.003634:0.003059:0.003922:0.003634:0.006536:0.005804:0.003634:0.005804:0.006536:0.010170:0.006536:0.005804:0.006536:0.006536:0.002235:0.004353:0.005804:0.005085:0.006732:0.006536:0.006706:0.005085:0.003634:0.006536:0.003634:0.005804:0.003660:0.004353:0.006261:0.004353:0.003268:0.003634:0.003634:0.005085:0.003477:0.005804:0.006536:0.009961:0.006536:0.006366:0.005085:0.003634:0.003451:0.003634:0.006340:0.006536:0.003268:0.004248:0.006366:0.004170:0.002784:0.003634:0.006824:0.006052:0.003516:0.005804:0.006536:0.010170:0.006536:0.005804:0.006536:0.006536:0.003059:0.005085:0.005804:0.003634:0.003451:0.003634:0.006536:0.006327:0.003516:0.006366:0.004353:0.003817:0.005085:0.006353:0.006536:0.006366:0.003634:0.006536:0.003634:0.006536:0.006288:0.003268:0.003438:0.006536:0.005804:0.003673:0.006288:0.004170:0.006366:0.006536:0.006209:0.005634:0.003634:0.003268