ࡱ> wyv bjbj errZL$222P<t2!22HHH###k!m!m!m!m!m!m!$#V&!r##rr!HH!:::rLHHk!:rk!::# H`hv W!!0! $'46$'# $'# 4#0S":u###!!j###!rrrr$'######### : PROTOCOL and DATA SPECIFICATION All sections of the protocol should be completed. Protocols that do not comply with these criteria or are of poor quality may be rejected. Anonymised data only will be provided. 1.1 Project Title 1.2 Background Explain reason for the study and include any other essential background information, e.g. related research 1.3 Overall Purpose (Aim) State the study hypothesis or objective of investigation 1.4 Research Questions Describe the research questions you wish to answer using PCCIU data. 1.5 Study population Define the source and study population. Provide criteria on how the study population is going to be drawn from PCCIU databases, e.g. exclusion, inclusion criteria. 1.6 Study design Describe type of study, e.g. case-control, cohort or cross-sectional study 1.7 Exposure of interest Describe exposures e.g. Smoking, Female Gender, Age. 1.8 Outcome of interest e.g. Morbidity Define clinical outcome of interest. Comment on how the outcome of interest is going to be ascertained, e.g. Read codes, first presentation of disease. If the researcher has knowledge and access to 5-byte Read version 2, then they may provide datasets (preferably with both Read code and term included). The PCCIU-R team will be able to advise on dataset development if required. The data management team will require a detailed specification. See below for an example. 1.9 Outcome of interest e.g. Other Define non-clinical outcomes of interest, e.g. prescription, blood pressure measurement. A list should be provided of all other terms or drug codes of interest. 1.10 Observational period Depending on the study design, provide information on the time period your interested in e.g. all cases of angina in year 2003 to 2004. 1.11 Analysis What are your proposed methods of analysis e.g. logistic regression with adjustment for confounding. Also provide brief details of who will be carrying out the analyses. 1.12 RESEARCH and INFORMATION GOVERNANCE 1.12.1 Institutional Data Protection Registration Number Please provide this number for the institution in which you are based i.e. the institution to which the contract for this data provision will be issued. 1.12.2 Ethical Approval What ethical issues are associated with the use of PCCIUR data in relation to your proposed study? (Please write) Is there a risk of disclosure of an individuals identity in this study? (For example, individuals with rare diseases) (Please circle)Yes / No /Unsure 1.12.3 Data Storage, Retention and Destruction How will the data be stored and where e.g. on a secure backed up PC in locked room in the Centre of Academic Primary Care in the 51cg. For what period of time will the data be retained? How will the data be destroyed at the end of the retention period? 1.13 Contact details for lead applicant Please note, for student projects, the student cannot be lead applicant. The students supervisor should be the named lead applicant. Title: ____ Name: ___________________________________________________________ Position: _________________________________________________________ Qualifications: ____________________________________________________ Full Postal Address: _______________________________________________ _______________________________________________ Postcode: _________________ Telephone: _________________ Email: _______________________ If the lead applicant is not based in a Higher Education Institution, NHS organisation or Government department, they may be required to submit a one-page CV and additional supporting material. 1.14 Individuals with access to this data The data will not be released to any other individual(s) or organisation(s) other than below not directly connected with the work specified in the protocol and specification without prior approval from PCCIU-R, except in the form of non-disclosive statistical tables or conclusions. Named individuals to have access to dataJob TitleOrganisation 1.15 Funding How do you propose to fund this work (charity grant, university funding etc.)? (The cost of processing, preparing and supplying PCCIUR data will be charged to the applicant. It is the applicants responsibility to ensure that sufficient funds are available). 1.16 Timetable Describe your timetable for your project. (Applicants should note that application process takes between three to four months from the point at which the completed protocol is submitted). 1.17 Data Transfer Data will be supplied using FTP. 1.18 Plan for dissemination How will the results be disseminated, e.g. conference abstracts or publication. 1.19 Data Specification Full Field nameDataTypeEnglish descriptionRead group IDCoding of variablee.g. GlucocorDdate/timeDate/time variableLatestMissing = null Measurements (multiple rows per patient) e.g. SysBPBooleanBinary variable to denote recording of systolic blood pressureWhere recorded can have multiple rows From carevalues (or equivalent) table Missing = null Suggested peer reviewers for protocol Please list at least three suitable peer reviewers for this application. Reviewers should not be directly involved with the proposed study and should be outside base department. ReviewerTitleNameAddressEmailAny known conflict of interest?1 2 3       FILENAME \p \* MERGEFORMAT PROTOCOL060312.doc  !Th i k      . 4 6 7 M ĻĮꊡhRB*aJphhG\B*aJphhG\5B*\aJphhs7@5B*\aJphh}g5B*\aJphhR5PJ\h}gh}g5PJ\hs7@5PJ\ hG\PJ hRh]7h]7hG\hR hG\5\ hR5\2 !   M Fgd)gdgd)g $da$gd)g X f ? FK_ǽ۰ۘ{ncXhyO5PJ\aJhL~5PJ\aJhyO5B*\aJphhRB*aJphhRB*phhR5B*\phhyO5B*\phh}g5B*\aJphhs7@5B*\aJphh65B*aJphh8gB*aJphhVpB*aJphhG\B*aJphhR5B*\aJphhG\5B*\aJph+)<ƾƴ꩞zrgYNh 5PJ\aJh9h95PJ\aJh/q5PJ\aJhyOB*phhG\B*phhh)gPJhG\PJaJhi#5PJ\aJh}g5PJ\aJhG\5PJ\aJh)gh)g6CJh)gh)g6h)gh)g5PJ\aJhihiPJ\aJhiPJ\aJhyO5PJ\aJhi5PJ\aJ,-./g}kd$$Ifl0"} t0"#644 layt)g $$Ifa$gd)g $Ifgd/qgd)g||ss $Ifgd)ggd)g}kd$$Ifl0"} t0"#644 layt)g{{ $Ifgd)g{kd$$Ifl0L" t0O#644 layt{{ $Ifgd)g{kd$$Ifl0L" t0O#644 layt=[\zzzzzzzzzzzzgd)ggdyO{kd$$Ifl0L" t0O#644 layt<=J[}>?Dhiʽʴ|sgs\QFhyO5PJ\aJh/q5PJ\aJh?=hyOOJQJhahyO56CJhahyOCJ hahyOhahyOOJQJhyOOJQJhOShyOPJhOShyO5 h/q5hi#h|p\h|pPJ\aJh35B*\aJphhi5B*\aJphh.PJ\aJhi#PJ\aJhi#hi#PJ\aJh95PJ\aJ9:x|}?i $$IfgdaYd^`gdyOgdyO$a$gd)ggd)g_SSS d$IfgdaYkd$$IflF R t0TTTTTTf    44 lapytaY_SSS d$IfgdaYkdM$$IflF R t0TTTTTTf    44 lapytaY]QQQ d$IfgdaYkd$$IflF R t0TTTTTTf    44 lapytaY_SSS d$IfgdaYkd$$IflF R t0TTTTTTf    44 lapytaY_SSS d$IfgdaYkdm$$IflF R t0TTTTTTf TTT TTT TTT TTT44 lapytaY_SSS d$IfgdaYkd/$$IflF R t0TTTTTTf TTT TTT TTT TTT44 lapytaY_SSS d$IfgdaYkd$$IflF R t0TTTTTTf TTT TTT TTT TTT44 lapytaY_OJBJJ$a$gdaYgdyO0d^`0gdyOkd$$IflF R t0TTTTTTf TTT TTT TTT TTT44 lapytaY>0dej}~ŸxqgcXQGhyOCJnH tH  hahyOhahyOOJQJhyOhg'hyO5\ h/q5\hp!PJaJh/q5PJ\aJhp!5PJ\aJhRPJaJhR5B*\aJphh/q5B*\aJphhi5B*\aJphhRhyOB*CJphhyOB*phhyO5B*\phh/q5B*\phh$~PJaJhyOPJaJde}~ $$Ifgd gdyOgd)g kdu$$IflrL $  t20TTTTTT44 lap2yt  $Ifgd $d$Ifa$gd ()R\e    AB9WXȶꟕ|tjtfhD~qhhP:5\hhP:5h{ Bh{ B\ hD~q\ h{ B\ hD~q5\hD~qhD~q5\ hP:5\ hyOCJhyOCJnH tH #hEhyO5CJ^JaJnH tH hEhyO5CJaJhahyOCJhEhyOOJQJ^JhEhyOCJhEhyOCJnH tH (kd $$IflrL $  t20TTTTTTTTTTTTTTTTTTTTTTTTTT44 lap2yt $d$Ifa$gd kd $$IflrL $  t20TTTTTT44 lap2yt $d$Ifa$gd kd $$IflrL $  t20TTTTTT44 lap2yt  !$d$Ifa$gd !"kd/ $$IflrL $  t20TTTTTT44 lap2yt "#$%&'$d$Ifa$gd '(kdZ$$IflrL $  t20TTTTTT44 lap2yt ()R]e $Ifgd $d$Ifa$gd gd kd$$IflrL $  t20TTTTTTTTTTTTTTTTTTTTTTTTTT44 lap2yt  $Ifgd $d$Ifa$gd  kd$$IflrL $  t20TTTTTTTTTTTTTTTTTTTTTTTTTT44 lap2yt       $Ifgd $d$Ifa$gd kd$$IflrL $  t20TTTTTTTTTTTTTTTTTTTTTTTTTT44 lap2yt  $Ifgd $d$Ifa$gd kd0$$IflrL $  t20TTTTTTTTTTTTTTTTTTTTTTTTTT44 lap2yt  $Ifgd $d$Ifa$gd kdi$$IflrL $  t20TTTTTTTTTTTTTTTTTTTTTTTTTT44 lap2yt B 8 $Ifgd)g $$Ifa$gdgd)ggdyO 89;<=8***$x$Ifa$gdkd$$Iflֈ|%60D + t0>7644 layt=>?@AB x$IfgdBCEFG8***$x$Ifa$gdkd]$$Iflֈ|%60D + t0>7644 laytGHIJKL x$IfgdLMOPQ8***$x$Ifa$gdkd$$Iflֈ|%60D + t0>7644 laytQRSTUV x$IfgdVWXYZ\83331gd)gkd$$Iflֈ|%60D + t0>7644 laytXZ[]^`acdfghi h)haYhL~mHnHuhaYmHnHuhaYjhaYUhMhL~hD|~jhD|~Uha#S \]_`bcefghgd)ggd),1h. A!"#$% 51h0:pP:A .!"#$% $$If!vh#v}#v:V l t0"#65}5yt)g$$If!vh#v}#v:V l t0"#65}5yt)g$$If!vh#v#v:V l t0O#655yt$$If!vh#v#v:V l t0O#655yt$$If!vh#v#v:V l t0O#655yt$$If!vh#v` #v#v\ :V l t0TTTTTTf555RpytaY$$If!vh#v` #v#v\ :V l t0TTTTTTf555RpytaY$$If!vh#v` #v#v\ :V l t0TTTTTTf555RpytaY$$If!vh#v` #v#v\ :V l t0TTTTTTf555RpytaY$$If!vh#v` #v#v\ :V l t0TTTTTTf555R/ TpytaY$$If!vh#v` #v#v\ :V l t0TTTTTTf555R/ TpytaY$$If!vh#v` #v#v\ :V l t0TTTTTTf555R/ TpytaY$$If!vh#v` #v#v\ :V l t0TTTTTTf555R/ TpytaY)$$If!vh#v#v#v#v2 #vA:V l  t20TTTTTT55555ap2yt 7$$If!vh#v#v#v#v2 #vA:V l  t20TTTTTT55555/ Tap2yt )$$If!vh#v#v#v#v2 #vA:V l  t20TTTTTT55555ap2yt )$$If!vh#v#v#v#v2 #vA:V l  t20TTTTTT55555ap2yt )$$If!vh#v#v#v#v2 #vA:V l  t20TTTTTT55555ap2yt )$$If!vh#v#v#v#v2 #vA:V l  t20TTTTTT55555ap2yt 7$$If!vh#v#v#v#v2 #vA:V l  t20TTTTTT55555/ Tap2yt 7$$If!vh#v#v#v#v2 #vA:V l  t20TTTTTT55555/ Tap2yt 7$$If!vh#v#v#v#v2 #vA:V l  t20TTTTTT55555/ Tap2yt 7$$If!vh#v#v#v#v2 #vA:V l  t20TTTTTT55555/ Tap2yt 7$$If!vh#v#v#v#v2 #vA:V l  t20TTTTTT55555/ Tap2yt $$If!vh#v#v0#v#vD #v#v+:V l t0>7655055D 55+yt$$If!vh#v#v0#v#vD #v#v+:V l t0>7655055D 55+yt$$If!vh#v#v0#v#vD #v#v+:V l t0>7655055D 55+yt$$If!vh#v#v0#v#vD #v#v+:V l t0>7655055D 55+yt^ 2 0@P`p2( 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p8XV~_HmH nH sH tH @`@ G\NormalCJ_HaJmH sH tH DA D Default Paragraph FontRi@R  Table Normal4 l4a (k (No List >B@> G\ Body Text$da$aJ<P@< G\ Body Text 2$a$aJjR@j G\Body Text Indent 2>d^`>CJOJQJaJhZO"Z G\ Table Heading <<5B* CJOJQJaJph]4@24 -KHeader  9r 4 @B4 -KFooter  9r H@RH 9 Balloon TextCJOJQJ^JaJjcj  Table Grid7:V0<@r< g' Comment TextCJaJe@ g'HTML Preformatted7 2( Px 4 #\'*.25@9CJOJQJ^JaJmH sH PK![Content_Types].xmlN0EH-J@%ǎǢ|ș$زULTB l,3;rØJB+$G]7O٭V$ !)O^rC$y@/yH*񄴽)޵߻UDb`}"qۋJחX^)I`nEp)liV[]1M<OP6r=zgbIguSebORD۫qu gZo~ٺlAplxpT0+[}`jzAV2Fi@qv֬5\|ʜ̭NleXdsjcs7f W+Ն7`g ȘJj|h(KD- dXiJ؇(x$( :;˹! I_TS 1?E??ZBΪmU/?~xY'y5g&΋/ɋ>GMGeD3Vq%'#q$8K)fw9:ĵ x}rxwr:\TZaG*y8IjbRc|XŻǿI u3KGnD1NIBs RuK>V.EL+M2#'fi ~V vl{u8zH *:(W☕ ~JTe\O*tHGHY}KNP*ݾ˦TѼ9/#A7qZ$*c?qUnwN%Oi4 =3N)cbJ uV4(Tn 7_?m-ٛ{UBwznʜ"Z xJZp; {/<P;,)''KQk5qpN8KGbe Sd̛\17 pa>SR! 3K4'+rzQ TTIIvt]Kc⫲K#v5+|D~O@%\w_nN[L9KqgVhn R!y+Un;*&/HrT >>\ t=.Tġ S; Z~!P9giCڧ!# B,;X=ۻ,I2UWV9$lk=Aj;{AP79|s*Y;̠[MCۿhf]o{oY=1kyVV5E8Vk+֜\80X4D)!!?*|fv u"xA@T_q64)kڬuV7 t '%;i9s9x,ڎ-45xd8?ǘd/Y|t &LILJ`& -Gt/PK! ѐ'theme/theme/_rels/themeManager.xml.relsM 0wooӺ&݈Э5 6?$Q ,.aic21h:qm@RN;d`o7gK(M&$R(.1r'JЊT8V"AȻHu}|$b{P8g/]QAsم(#L[PK-![Content_Types].xmlPK-!֧6 0_rels/.relsPK-!kytheme/theme/themeManager.xmlPK-!0C)theme/theme/theme1.xmlPK-! ѐ' theme/theme/_rels/themeManager.xml.relsPK] . CEGIKKKKKKKN <X"&B!"'( 8=BGLQV\ !#$%'()*+,-./0123456789:;<=>?@AC-@N8@0(  B S  ?;;;{ {  9*urn:schemas-microsoft-com:office:smarttagsplace=*urn:schemas-microsoft-com:office:smarttags PlaceName=*urn:schemas-microsoft-com:office:smarttags PlaceType YZ\]_`bcef/5P\Z\]_`bcef3333Xf&  ?cdejB9ACKMUWYZZ\]]_`bcefYZZ\]]_`bcefhMXZ"0^`0o(0^`0o(.0^`0o(..0^`0o(... 88^8`o( .... 88^8`o( ..... `^``o( ...... `^``o(....... ^`o(........MXGFw`k 3-KyO.}gv|pVpp!i#]7>s7@{ B|DLa#S5VaY1[[`_ab5ere8g,hi/qD~q;xd}y$~L~D|~_ag'9)g(viX< t$P:.Z);$Q "R'aM m6558@G\Z\@@UnknownG*Ax Times New Roman5Symbol3. *Cx ArialI. ??Arial Unicode MS5. .[`)Tahoma?= *Cx Courier NewA$BCambria Math"hp)p)&/+ &/+ &!x24PP 3qHP ?G\2!xx 8PCCIU data  Protocol Template and example specification Colin Simpson Rebecca, P.J. Oh+'0  < H T `lt|<PCCIU data Protocol Template and example specificationColin Simpson Normal.dotmRebecca, P.J.2Microsoft Office Word@@뢝@`h@`h/+՜.+,D՜.+,@ hp  !$College of Life Sciences & Medicine& P 9PCCIU data Protocol Template and example specification TitleP <D_NewReviewCycle  !"#$%&'()*+,-./0123456789:;<=>?@ABCDFGHIJKLMNOPQSTUVWXYZ[\]^_`abcdeghijklmopqrstuxRoot Entry F󿈝zData E1TableR4'WordDocumenteSummaryInformation(fDocumentSummaryInformation8nCompObjr  F Microsoft Word 97-2003 Document MSWordDocWord.Document.89q