000			02481cam a22003977i 4500
001			19549620
005			20230322160822.0
008			170310t20172017enka b 001 0 eng d
010			_a2017936521
020			_a9780128047293
020			_a0128047291
035			_a(OCoLC)ocn960845366
040			_aBTCTA _beng _cBTCTA _erda _dYDX _dBDX _dOCLCO _dOCLCF _dOCLCO _dWSU _dDLC
042			_alccopycat
050	0	0	_aR853.C55 _bC665 2017
060		4	_aW 20.55.C5
082	0	4	_a615.5072/4 _223
245	0	2	_aA comprehensive and practical guide to clinical trials / _cedited by Delva Shamley, Brenda Wright, The Clinical Research Centre at the University of Cape Town, Cape Town, Western Cape Province, South Africa.
264		1	_aLondon, United Kingdom ; _aSan Deigo, CA, United States : _bElsevier/AP, Academic Press, an imprint of Elsevier, _c[2017]
264		4	_c©2017
300			_axiv, 196 pages : _billustrations ; _c23 cm
336			_atext _btxt _2rdacontent
337			_aunmediated _bn _2rdamedia
338			_avolume _bnc _2rdacarrier
504			_aIncludes bibliographical references and index.
505	0		_aIntroduction to clinical trials / Brenda Wright -- Clinical trial phases / Brenda Wright -- Setting up of site, site assessment visits, and selection / Brenda Wright -- Regulatory requirements / Inge Vermeulen -- Contracts and agreements / Brenda Wright -- Protocol, informed consent documents, and investigator brochure / Brenda Wright -- Planning / Brenda Wright -- Recruitment and retention / Brenda Wright -- Training / Brenda Wright -- Data management / Annemie Stewart -- Investigational medicinal product (IMP) management / Wynand Smythe and Nicky Kramer -- Collecting, processing, and shipment of blood and urine samples / Brenda Wright -- Source document / Brenda Wright -- Screening, treatment, and safety follow-up visit / Brenda Wright -- Quality management / Brenda Wright -- Monitoring, close-out visits, and archiving / Brenda Wright -- Audits and inspections / Brenda Wright.
650		0	_aClinical trials _vHandbooks, manuals, etc.
650		2	_aClinical Trials as Topic.
650		7	_aClinical trials. _2fast _0(OCoLC)fst00864429
655		7	_aHandbooks and manuals. _2fast _0(OCoLC)fst01423877
700	1		_aShamley, Delva, _eeditor.
700	1		_aWright, Brenda, _eeditor.
906			_a7 _bcbc _ccopycat _d2 _encip _f20 _gy-gencatlg
942			_2NLM _cBK _n0
999			_c3151 _d3151