Completing the SDRN Study Tracker

Transcription

1 Cmpleting the SDRN Study Tracker Clinical S.O.P. N.: 30 Versin 2..1 Cmpiled by: Apprved by: Review date: Nvember 2016

2 Cmpleting the SDRN Study Tracker S.O.P. N. 30 Versin 2.1 DOCUMENT HISTORY Versin Detail f purpse / change Authr / edited Date edited number by 1.0 New SOP Luise Greig 2.0 Additinal infrmatin added t the SOP Luise Greig June Additinal infrmatin added t the SOP in Luise Greig June 2013 relatin t new data t be cllected fr the CSO annual reprt 2.2 Minr changes made t the additinal infrmatin added t this SOP in June Luise Greig Nvember 2014 All SDRN SOPs can nw be dwnladed frm: 2 f 6

3 Cmpleting the SDRN Study Tracker S.O.P. N. 30 Versin Intrductin ICH GCP states that systems with prcedures that assure the quality f every aspect f the trial shuld be implemented. 2. Objective The tracker shuld functin as a pint f reference fr site staff t help them in the planning f their wrklad when determining what studies t undertake at any given time. 3. Backgrund The purpse f the study tracker is t supprt the SDRN management team reprt the level f research activity at Diabetes Research active sites acrss Sctland. The infrmatin cllected is used t cmpse the annual reprt that is sent t the Chief Scientist Office at the end f each year. This SOP details the prcedure t be used when cmpleting the SDRN study tracker. 4. Respnsibility It is the respnsibility f the research nurse/study c-rdinatr based at the lcal site t update the tracker n a mnthly basis and return the cmpleted tracker t the SDRN C-rdinating ffice in Dundee. The tracker shuld be updated n the last day f each mnth. 5. Prcedure The clumns in the spreadsheet shuld be cmpleted as fllws Clumn A - SDRN N: The SDRN ffice assigns this number when a study is put n the SDRN Prtfli Database. The number will be entered n the study tracker by SDRN staff as sn as ne is assigned t a specific study. Clumn B - Study Name/N: The study prtcl number/acrnym shuld be recrded here as this ensures that multi centre studies are entered nt the database under the crrect name. Clumn C - Spnsr: Recrd the name f the rganisatin respnsible fr the initiatin and management f the clinical trial in this clumn. Clumn D - PI/Lead Nurse: Recrd the name f the Principal Investigatr and lead nurse/crdinatr at yur site fr each study. Clumn E - Prpsed Start Date: As sn as yu are cntacted regarding a ptential trial enter the study nt the tracker and recrd the prpsed start date when patient recruitment t the study will pen. All SDRN SOPs can nw be dwnladed frm: 3 f 6

4 Cmpleting the SDRN Study Tracker S.O.P. N. 30 Versin 2.1 Clumn F - Prpsed End Date: As sn as yu are cntacted regarding a ptential trial enter the study nt the tracker and recrd the date that it is anticipated when patient recruitment t the study will clse. Clumn G - Date f R & D Permissins/SIV: Recrd the date yur R & D department apprved the study (i.e., green light is given fr study t g ahead) and the date the Site Initiatin Visit is carried ut. Once studies have R & D apprval r the Site Initiatin Visit has been carried ut then yu shuld recrd the infrmatin in the sectin titled Active cmmercial studies Active academic studies (This infrmatin has been requested by the Chief Scientist Office Sctland in rder t lk at the time between R & D apprval being granted r the SIV being carried ut and the date f the First Patient First Visit - FPFV.) Clumn H Date f FPFV: Recrd the date that yu see yur first patient fr their first visit. This infrmatin shuld be recrded in the sectin titled Active cmmercial studies Active academic stage Clumn I - In Set-up, Recruiting, In Fllw-up, Clsed: When yu are cntacted regarding a ptential study yu shuld enter the study details nt the tracker and recrd the stage that it is currently at i.e., enquiry, feasibility, in set-up, pending etc. The tracker is divided int sectins t make this prcess clearer. Infrmatin relating t studies in the recruiting, in fllw-up and clsed stage signifies the fllwing Recruiting is when yu are actively recruiting new patients t a study. In fllw-up is when the study has clsed t new recruits, but patients are still being seen the research team. Clsed is when patients are n lnger being seen by the research team and the study has been clsed. Infrmatin relating t studies at the enquiry / feasibility / pending r set-up stage shuld be recrded in the sectin titled - Cmmercial studies at the feasibility / pending r set-up stage Academic studies at the feasibility / pending r set-up stage Clumn J - Recruitment Target: In this field yu shuld recrd the number f participants that yu agree as a site, with the spnsr, t recruit int the study. This infrmatin is available in the mcta a cpy f which shuld be retained in the study site file. Clumn K N. f new patients recruited this mnth: In this clumn recrd the number f new patients recruited t a particular study in any given mnth. All SDRN SOPs can nw be dwnladed frm: 4 f 6

5 Cmpleting the SDRN Study Tracker S.O.P. N. 30 Versin 2.1 Clumn L Ttal number f patients screened: In this clumn recrd the cumulative number f patients that have cnsented t take part in a study and cmpleted visit 1. (NB nt the number f ntes screened.) Clumn M Ttal number f patients randmised: In this clumn recrd the number f patients wh are successfully randmised int a study. Clumn N - Per Patient Fee/Grant: Fr cmmercial studies please recrd the agreed per patient fee. This infrmatin shuld be stated in the mcta fr the study, a cpy f which shuld be in the study site file. Fr academic studies recrd the value f the grant awarded fr the study. Clumn O - Minimum Dataset Frm Cmpleted: All studies n the SDRN Prtfli Database require a Minimum Database Frm t be cmpleted. Please indicate that a SDRN Minimum Dataset Frm has been cmpleted by entering Yes in the relevant field. If yu enter N in this clumn then yu need t cmplete a SDRN Minimum Dataset Frm. The frm can be dwnladed frm the SDRN website and then sent t the SDRN Office in Dundee. Clumn P - Cmments: Please recrd all infrmatin yu cnsider relevant r significant. Example f pssible cmments: Feasibility questinnaire cmpleted n 00/00/00 and sent t cmpany. Site selectin visit carried ut n 00/00/00. Site selected n 00/00/00. Awaiting site initiatin visit/ initiatin visit due 00/00/00. Attended investigatr meeting. Study cming t a clse/data lck sn. Awaiting clse ut mnitring visit. Insulin initiatin study. Insulin titratin study. Insulin switch study. Insulin cmparatr study. Cardivascular utcme study. Study terminated by the cmpany. Lng term endpint study. FPFV (First patient First visit planned fr 00/00/00) All SDRN SOPs can nw be dwnladed frm: 5 f 6

6 Cmpleting the SDRN Study Tracker S.O.P. N. 30 Versin 2.1 (APPENDIX 1) All SDRN SOPs can nw be dwnladed frm: 6 f 6