A Randomized Controlled Trial of Enzymatic Debridement of Pressure Ulcers With Clostridial Collagenase Ointment (SANTYL®) or Hydrogel (SoloSite®)
Phase: PHASE4
Conditions: Pressure Ulcer
Sponsor: Smith & Nephew, Inc.

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Protocol p. I of 52 

SM ITH & NEPH EW - Confidential 
C linical Protocol # 017-101-09-036 
11. Study Records* 
Version 2 
05 May2016 
Maintain adequate and accurate records of all clinical study data, which are generally more exact 
and complete than those kept in ordinary medical practice. 
a. Keep study records and source documents until the Sponsor has provided written 
approval for their destruction. 
b. Ensure that data are rcconled on source documents and Jransferred to the approp1iate 
Case Report Foru1s for each study participant. 
c. Adhere to Case Report Form Completion Guidelines provided by the Sponsor. 
12. Monitoring and Auditing 
Permit monitoring, auditing, and access to all study documents and make them available for 
inspection and copying by representatives of the Sponsor, the IRB/IEC, regulalory authorities, 
and other inspectors. 
Notify the Sponsor of any wriUen or verbal communication from a regulatory authority or 
inspector as soon as it occurs and work with the Sponsor to prepare a response to all such 
communication. 
• Smith & Nephew, Inc. requires that all records relating to the conduct of this study be held by the Investigator for a 
period of al least 2 years following the approval of the lest article or removal of the rND. If the Investigator retires, 
relocates, or for any other reasoo withdraws from responsibility of keeping the study records, custody must be 
transferred to the Sponsor or to a person who will accept responsibility and is approved by the Sponsor. Study 
records will not be destroyed without the written approval uf the Sponsor. 
CPT-5.8 
Prolocol p. 51 of 52 

SMITH & NEPHEW - Confiden tial 
C linical Protocol # 017-101-09-036 
13. RIP AA Authorization 
Version 2 
05 May2016 
For studies conducted in the US only, obtain written HlPAA authorization (or provide a waiver) 
for use and disclosure of protected health informalion (Pill) from each study participant (or legal 
representative) enrolled in U1e sludy using your cw..-ent autbmization form before performing any 
study-specific procedw·es on the study participant. 
18.4 
D ECLARATION OFliELSINIO 
llus clinical study will be performed in compliance with the ethical principles of the Declaration 
of Helsinki and Good Clinical Practice (GCP), effective for sludies commencing after July 1996 . 
CPT-5.8 
.Prot()4.!01 p ~ of Sl.