Completing the Case Report Form

Transcription

1 Cmpleting the Case Reprt Frm Clinical S.O.P. N.: 14 Cmpiled by: Apprved by: Review date: Nvember 2016

2 DOCUMENT HISTORY Versin number Detail f purpse / change Authr / edited by 1.0 New SOP Shna Brearley 2.0 Infrmatin added regarding electrnic Luise Greig / CRFs Mira Dryburgh Date edited June 2012 All SDRN SOPs can nw be dwnladed frm: 2 f 5

3 1. Intrductin The CRF, whether paper r electrnic, cntains the surce data fr much f the infrmatin regarding a clinical trial and shuld be treated as an essential dcument fr cnducting a clinical trial t ICH GCP guidelines. 2. Objectives T describe the prcedure used within the Scttish Diabetes Research Netwrk fr cmpleting Case Reprt Frms (CRF) Data recrded n a CRF can be generated frm surce data r dcuments, r can be directly cllected in the CRF in accrdance with the prtcl. 3. Respnsibility Only nurses wh have been trained in this prcedure and deemed cmpetent shuld cmplete this prcedure. The spnsr/investigatr shuld make sure that all clinical data recrded n a paper r electrnic CRF, are accurate, cmplete and legible. 4. Equipment Black ballpint pen. Cmputer fr e-crfs 5. General Pints CRFs are the fficial dcumentatin f the trial fr bth Spnsr and regulatry authrities. The data cllected n the CRF is used directly as the basis fr the trial reprt and any publicatins as well as making up part f the data fr regulatry apprval f a new drug. The CRF shuld be cmpleted as fully as pssible whilst the patient is present. The case reprt frm is used in a study t cllect necessary infrmatin abut: The participant Study prcedures Study interventins Administratin f the Investigatinal Prduct (if applicable) Outcme f assessments and tests Adverse events The CRF shuld be cmpleted prmptly and accurately and cmpleted in accrdance with the study prtcl. The study design will prvide the visit schedule and when visits are due. All SDRN SOPs can nw be dwnladed frm: 3 f 5

4 Data recrded in the CRF, which are drawn frm surce data r dcuments, shuld crrespnd t the data appearing in these dcuments. CRFs shuld be kept in a secure lcatin during the curse f the study and archived in accrdance with GCP regulatins. 6. Prcedure fr paper CRFs Always use black ink. If the CRF is printed n carbnless duplicatin paper always make sure that a suitable separatr is inserted under the frm being cmpleted. Cmplete all items/cmments in the space prvided. If the infrmatin is unavailable r a test is nt perfrmed, recrd NA (nt applicable), NK (nt knwn) r ND (nt dne) in the apprpriate place. Keep cmments cncise. Errrs shuld be crssed ut with a single line s as t remain legible and the new data written next t the incrrect data. All alteratins must be initialled and dated. D nt use crrectin fluid. Where apprpriate, indicate chices by marking the relevant bx with a crss, r a tick accrding t the spnsring cmpany requirements. When the answer is a chice f scres, recrd a discrete number, nt a cmbinatin e.g. recrd 2 nt 1/2. If indicated mre than ne discrete number may be recrded. Avid abbreviatins. Recrd dates as day/mnth/year e.g. 1 st May 2006 will be dcumented as 01/05/2006. Recrd times in 24hur clck e.g. 2:00pm as 14:00, midnight as 00:00. Please ensure all frms are cmpleted and signed. Please d nt cmplete any shaded areas in the CRF. If the subject des nt cmplete the study, please dcument the reasn fr discntinuatin n the study cnclusin summary page. 7. Prcedure fr electrnic CRFs Electrnic CRFs will be cmpleted using a study specific laptp cmputer, r a Web based applicatin may be used t access the e-crf. Electrnic CRFs enable data t be typed directly int cmputer fields and transmitted electrnically t Data Management. All SDRN SOPs can nw be dwnladed frm: 4 f 5

5 In rder t access the electrnic database yu will be prvided with individual lgin infrmatin that yu will need t stre safely. Ensure yu have the necessary patient data / surce dcuments etc., if nt entering data at pint f seeing the patient. Prcess fr electrnic data capture Data capture Data entry Data querying Only the site staff with apprpriate access may mdify electrnic data entries. All SDRN SOPs can nw be dwnladed frm: 5 f 5