Miscel

Question 1

CRF

Do czego sluzy

Answer 1

Case report form

It is a tool used to collect all data from each participating subject in clinical trial. Sponsor develops or outsources CRF development to collect the specific data needed to get the hypotheses and find answers to their research questions

Question 2

CRF definicja

Answer 2

Printed, optical or electronic document designed to record all the protocol required information to be reported to the sponsor on each trial subject

Alternatywnie
CRF is a tool designed by sponsor to capture the transcription of protocol specific data from source document to CRF

Question 3

Elements CRF(3)

Answer 3

1. Header information
	identifying informations
	site/center number
	subject identification number(deidentification)
	Protocol identification number

2. Safety modules(standard crf templates)
	demographics 
	adverse events
	vital signs
	medical history
	physical examination
	concomitant medication
	patient disposition

3. Efficacy modules
   it is designed based on the diagnostics required for the study for example: bio marker pages, imaging pages, pharmacokinetic sampling

Question 4

CTP / Clinical Trial Protocol