Information Sheet Guidance 
for Sponsors, Clinical 
Investigators, and IRBs 
 
Frequently Asked Questions  
Statement of Investigator  
(Form FDA 1572) (Revision 1) 
 
     
 
 
DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only. 
 
Comments and suggestions regarding this draft document should be submitted within 60 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance.  Submit electronic comments to https://www.regulations.gov.  Submit written 
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD  20852.  All comments should be identified with the 
docket number listed in the notice of availability that publishes in the Federal Register. 
 
For questions regarding this draft document, contact (CDER) Paul Gouge, 301-796-3093, or 
(CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-402-8010.  
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Good Clinical Practice (OGCP) 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
 
May 2021 
Procedural 
Revision 1 
 
30689434dftrev1.docx   
Information Sheet Guidance 
for Sponsors, Clinical 
Investigators, and IRBs  
 
Frequently Asked Questions  
Statement of Investigator 
(Form FDA 1572) (Revision 1) 
 
Additional copies are available from: 
 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs  
 
and/or 
 
Office of Communication, Outreach and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
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Silver Spring, MD 20993-0002 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances     
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Good Clinical Practice (OGCP) 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
May 2021 
Procedural 
Revision 1 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 1 
III.  GENERAL QUESTIONS (10, 11, AND 13) ................................................................... 2 
10.  Must investigators who conduct studies outside of the United States sign a 1572? ..................... 2 
11.  If a foreign clinical study is being conducted under an IND, what are the investigators 
responsibilities with respect to regional, national, or local laws and regulations? ............................... 2 
13.  If a sponsor chooses to conduct a foreign clinical study (or operate non-U.S. sites in a 
multinational study) under an IND and the investigators at these non-U.S. sites follow the 
recommendations in the ICH E6 Good Clinical Practice Consolidated Guidance, would the non-
U.S. investigators also be in compliance with FDAs IND requirements under 21 CFR part 312? .... 3 
IV.  SECTION #911:  COCOMMITMENTS, DATE, AND SIGNATURE OF 
INVESTIGATOR  WAIVER OF SIGNATURE ON FORM FDA 1572 ........................ 4 
39.  A sponsor may encounter situations in which investigators in foreign countries cannot or will 
not sign Form FDA 1572, yet the sponsor wishes to conduct the study at these sites under an IND.  
What can a sponsor do? .......................................................................................................................... 4 
40.  What should a sponsor submit to the IND when requesting a waiver of the 1572 signature 
requirement? ............................................................................................................................................ 4 
41. What documentation should a sponsor submit to show that they have an acceptable alternative 
course of action to satisfy the purpose of a signed Form FDA 1572?  Can you provide an example? 4 
42.  How and when should a sponsor submit the request to waive the signature requirement? .......... 5 
43.  Does the sponsor need to wait for the waiver request to be granted before initiating the study at 
that site? ................................................................................................................................................... 6 
44.  What does it mean to get a 1572 signature waiver? .................................................................... 6 
45.  Is the waiver of the 1572 signature requirement a distinctly different waiver than an IRB 
requirement waiver? ................................................................................................................................ 6 
46.  Are there any special considerations regarding Form FDA 1572 signature waivers and pediatric 
studies? ..................................................................................................................................................... 7 
APPENDIX:  EXAMPLES OF SPONSOR AND INVESTIGATOR COMMITMENTS ..... 8 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Information Sheet Guidance  
2  for Sponsors, Clinical Investigators, and IRBs1  
3  Frequently Asked Questions 
4  Statement of Investigator (Form FDA 1572) (Revision 1) 
5   
6   
7   
8  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
9  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not 
10  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
11  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
12  for this guidance as listed on the title page.   
13   
14   
15   
16   
17  I.  INTRODUCTION 
18   
19  This guidance is intended to assist sponsors, clinical investigators, and institutional review boards 
20  (IRBs) involved in clinical investigations of investigational drugs and biological products.  This 
21  guidance applies to clinical investigations conducted under 21 CFR part 312 (investigational new 
22  drug application (IND) regulations) and describes how to complete the Statement of Investigator 
23  (Form FDA 1572). 
24   
25   
26  II.  BACKGROUND 
27   
28  FDA has received questions about Form FDA 1572.  The most frequently asked questions 
29  (FAQs) are answered in the information sheet guidance for sponsors, clinical investigators, and 
30  IRBs Frequently Asked QuestionsStatement of Investigator (Form FDA 1572) (May 2010)2 (the 
31  Form FDA 1572 FAQ Guidance).  
32   
33  This guidance, when finalized, partially revises the Form FDA 1572 FAQ Guidance and answers 
34  additional questions received by FDA.  Questions not answered either in this guidance or in the 
35  Form FDA 1572 FAQ Guidance may be submitted to druginfo@fda.hhs.gov. 
36   
37  This guidance has been developed in response to multiple inquiries regarding waivers of the 
38  signature requirement on Form FDA 1572 and, when finalized, will explain FDAs current 
 
1 This guidance has been prepared by the Office of Medical Policy in the Center for Drug Evaluation and Research 
in cooperation with the Center for Biologics Evaluation and Research and the Office of Good Clinical Practice at the 
Food and Drug Administration.  
 
2 We update guidances periodically.  For the most recent version of a guidance, check the FDA guidance web page 
at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm. 
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
39  thinking regarding signature waivers.  Specifically, this draft guidance revises general questions 
40  10, 11, and 13 from the Form FDA 1572 FAQ Guidance and includes a new section (see 
41  questions 39 through 46) about waivers of the Form FDA 1572 signature requirement.   
42   
43  The contents of this document do not have the force and effect of law and are not meant to bind 
44  the public in any way, unless specifically incorporated into a contract.  This document is 
45  intended only to provide clarity to the public regarding existing requirements under the law.  
46  FDA guidance documents, including this guidance, should be viewed only as recommendations, 
47  unless specific regulatory or statutory requirements are cited.  The use of the word should in 
48  Agency guidances means that something is suggested or recommended, but not required. 
49   
50   
51  III.  GENERAL QUESTIONS (10, 11, AND 13)  
52   
53  10.  Must investigators who conduct studies outside of the United States sign a 1572? 
54  [Revised 2021] 
55   
56  If a clinical study is conducted at a foreign site under an IND, all FDA IND regulations, 
57  including the requirement to obtain a signed 1572 (21 CFR 312.53(c)(1)), must be met unless 
58  the sponsor requests and is granted a waiver that provides for specific exceptions.  In the case 
59  where a foreign investigator cannot or will not sign Form FDA 1572 (e.g., because regional, 
60  national, or local laws or regulations prohibit its signing), the sponsor may submit a request for 
61  a waiver of the 1572 signature requirement under 21 CFR 312.10 (see section [IV] of this 
62  guidance); alternatively, the site may operate as a non-IND site, in which case the study would 
63  be conducted as a non-IND study.   
64   
65  If a clinical study is conducted outside of the United States and the study is not under an IND, 
66  then the investigator need not sign a 1572.  If the study data from a non-IND site is to be 
67  submitted to support a marketing application (e.g., a new drug application (NDA)), the study at 
68  the non-IND site must be conducted in compliance with 21 CFR 312.120.  (Also, see question 
69  14 in the Form FDA 1572 FAQ Guidance.) 
70   
71  11.  If a foreign clinical study is being conducted under an IND, what are the investigators 
72  responsibilities with respect to regional, national, or local laws and regulations? 
73  [Revised 2021] 
74   
75  Investigators are responsible for complying with the applicable laws and regulations of the 
76  country in which the study is being conducted, regardless of whether the study is being 
77  conducted under an IND.  We recommend that sponsors obtain signed, written statements from 
78  investigators acknowledging their commitment to comply with regional, national, or local laws 
79  and requirements.  In addition, if a foreign clinical study is being conducted under an IND, the 
80  investigator must sign Form FDA 1572 (investigator statement) (21 CFR 312.53(c)(1)) and 
81  ensure that the study is conducted in accordance with the investigator statement and all other 
82  applicable regulations under 21 CFR part 312 unless the sponsor has requested, and FDA has 
83  granted, a waiver of the signature requirement.  If a waiver is granted, the sponsor and 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
84  investigator must ensure that the study is conducted in accordance with the terms of the waiver.  
85  (See section [IV] of this guidance.) 
86   
87  13.  If a sponsor chooses to conduct a foreign clinical study (or operate non-U.S. sites in a 
88  multinational study) under an IND and the investigators at these non-U.S. sites follow the 
89  recommendations in the ICH E6 Good Clinical Practice Consolidated Guidance,3 would the 
90  non-U.S. investigators also be in compliance with FDAs IND requirements under 21 CFR 
91  part 312? 
92  [Revised 2021] 
93   
94  Yes, with three exceptions.   
95   
96  The first exception is that the FDA requirements for IRBs under 21 CFR part 56 are slightly 
97  different than ICH E6 with respect to membership and function.  To address this issue, as 
98  described in question 12,4 the sponsor can request that FDA provide a specific waiver from the 
99  part 56 IRB requirements, allowing an IEC that complies with good clinical practice to substitute 
100  for the IRB.5   
101   
102  The second exception is that the requirements for informed consent under 21 CFR part 50 for 
103  particular clinical trials (e.g., emergency research under 21 CFR 50.24, clinical investigations 
104  involving pediatric subjects under subpart D) are more extensive than ICH E6 with respect to 
105  IRB responsibilities.  Our experience has not revealed that this difference has caused a conflict, 
106  but in the event of one, we would be willing to discuss a resolution with the sponsor on a case-
107  by-case basis.   
108   
109  The third exception is that ICH E6 does not require investigators to sign a Form FDA 1572.  To 
110  address this issue, the sponsor can request a specific waiver of the signature requirement on 
111  Form FDA 1572 pursuant to 21 CFR 312.10.  (See section [IV] of this guidance.) 
112   
113  If the investigator or sponsor concludes that there are other conflicting requirements, the sponsor 
114  may request a waiver from FDA from the specific requirement under 21 CFR 312.10.   
115   
116   
 
3 Throughout this guidance, ICH E6 refers to ICH guidance for industry E6(R2) Good Clinical Practice:  Integrated 
Addendum to ICH E6(R1) (February 2018). 
 
4 See question 12 in the information sheet guidance for sponsors, clinical investigators, and IRBs; Frequently Asked 
QuestionsStatement of Investigator (Form FDA 1572). 
 
5 See the information sheet guidance for sponsors, clinical investigators, and IRBs Waiver of IRB 
Requirements for Drug and Biological Product Studies (January 2006). 
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Draft  Not for Implementation 
117  IV.  SECTION #911:  COCOMMITMENTS, DATE, AND SIGNATURE OF 
118  INVESTIGATOR  WAIVER OF SIGNATURE ON FORM FDA 1572  
119   
120  39.  A sponsor may encounter situations in which investigators in foreign countries cannot or 
121  will not sign Form FDA 1572, yet the sponsor wishes to conduct the study at these sites under 
122  an IND.  What can a sponsor do? 
123  [New 2021] 
124   
125  Under FDA regulations, sponsors may submit requests to FDA for a waiver of an IND 
126  requirement (21 CFR 312.10).  Such submissions may include request for a waiver of the 
127  requirement that sponsors obtain an investigator signature on Form FDA 1572 (21 CFR 312.53 
128  (c)(1)).  Waiver of the signature on Form FDA 1572, when granted, enables the study at foreign 
129  sites to be and/or remain under an IND even though the investigator at those foreign sites cannot 
130  or will not sign Form FDA 1572, provided that the sponsor complies with the terms of the 
131  waiver.  (See below for further information regarding the waiver process and commitments.)   
132   
133  40.  What should a sponsor submit to the IND when requesting a waiver of the 1572 signature 
134  requirement? 
135  [New 2021] 
136   
137  1.  A clear statement that the sponsor is requesting a waiver of the signature requirement on 
138  the 1572 
139   
140  2.  The study title, protocol number, study sites, and investigator name(s) that would be 
141  subject to the waiver (Note:  If multiple sites are identified, the submission should 
142  identify which investigator(s) is associated with each site.) 
143   
144  A waiver request is required to contain at least one of the following (21 CFR 312.10(a)):  
145   
146  3.  The reason(s) each investigator cannot or will not sign Form FDA 1572 
147   
148  4.  The sponsors proposed alternative course of action to adequately satisfy the purpose of a 
149  signed Form FDA 1572 
150   
151  5.  Other information justifying a waiver 
152   
153  For FDA to consider granting the waiver request, it is important that the request addresses all of 
154  the items above. 
155   
156  41. What documentation should a sponsor submit to show that they have an acceptable 
157  alternative course of action to satisfy the purpose of a signed Form FDA 1572?  Can you 
158  provide an example? 
159  [New 2021] 
160   
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
161  There may be multiple ways for a sponsor to assure FDA that its alternative course of action 
162  adequately satisfies the purpose of a signed Form FDA 1572.  Although there may be other 
163  approaches, FDA recommends using the example and suggested templates found in the 
164  Appendix of this guidance, which will likely result in the most efficient review of the waiver 
165  request.  
166   
167  An alternative course of action could take the form of the submission of the following three 
168  items: 
169   
170  1.  Declaration by the sponsor that the regional (in the case of the European Union) or 
171  national regulatory authority is a member of the International Council for Harmonisation 
172  of Technical Requirements for Pharmaceuticals for Human Use (ICH) and has 
173  implemented the ICH E6 Guideline for Good Clinical Practice.  In addition, a 
174  determination by the sponsor that an investigators compliance with the ICH E6 
175  Guideline for Good Clinical Practice will ensure that the investigator and sponsor comply 
176  with their respective obligations under 21 CFR part 312, other than the signature 
177  requirement on Form FDA 1572.  (See the sponsor commitment example in the 
178  appendix.) 
179   
180  2.  Commitment by the sponsor to collect from each investigator for whom the signature 
181  requirement was waived, a completed but unsigned Form FDA 1572 that includes all 
182  information in sections 1 through 8 of Form FDA 1572 and a signed statement containing 
183  commitments equivalent to the commitments specified in Section 9 of Form FDA 1572.  
184  (Note:  In place of Form FDA 1572, the sponsor may choose to use an appropriate 
185  alternative template of its choice.)  (See the sponsor commitment example in the 
186  appendix.) 
187   
188  3.  Any templates or forms the sponsor intends to use to collect information and/or secure 
189  signed commitments from the applicable investigators.  (See the investigator commitment 
190  example in the appendix.) 
191   
192  We encourage sponsors considering other approaches to discuss these with the appropriate 
193  review division.  
194   
195  42.  How and when should a sponsor submit the request to waive the signature requirement? 
196  [New 2021] 
197   
198  The sponsor should submit the waiver request along with the necessary documentation 
199  supporting the waiver request in an amendment to the IND under which the study will be 
200  conducted.  
201   
202  The sponsor should submit the request to waive the signature on Form FDA 1572 when it 
203  determines that an investigator(s) cannot or will not sign Form FDA 1572. 
204   
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
205  If after a waiver request is granted, new investigators are added to this IND protocol who refuse 
206  or cannot sign the Form FDA 1572 and the sponsor wants to request a waiver of the Form FDA 
207  1572 signature requirement, they will need to submit a new waiver request applicable to these 
208  new investigators (21 CFR 312.53(c)(1); 21 CFR 312.10)).  When doing so, the sponsor should 
209  reference the protocol number, the date of the original request, and the date of any previous 
210  correspondence with FDA regarding the original waiver in a cover letter. 
211   
212  43.  Does the sponsor need to wait for the waiver request to be granted before initiating the 
213  study at that site? 
214  [New 2021] 
215   
216  Yes.  The Agency will inform the sponsor in writing whether the Agency is granting each 
217  request to waive the 1572 signature requirement under 21 CFR 312.10(b), whether the request 
218  requires more information, or whether the request is denied.  Only after either receiving a 
219  granted 1572 signature waiver or obtaining an appropriately signed Form FDA 1572 may a 
220  sponsor initiate the study at that site.   
221   
222  The sponsor should not assume that no response or a delayed response from the Agency means 
223  that the request for waiver has been granted. 
224   
225  If a waiver is granted, the sponsor should ensure that a copy of the waiver is maintained by the 
226  sponsor and the investigator so that it is available for review upon request. 
227   
228  44.  What does it mean to get a 1572 signature waiver? 
229  [New 2021] 
230   
231  The waiver does not waive the sponsors obligation to ensure that the investigator complies with 
232  the equivalent commitments expressed in the waiver request.  Likewise, the waiver does not 
233  waive the sponsors obligation to comply with all other applicable regulations. 
234   
235  Instead, after the Agency grants the waiver, the sponsor can conduct the study, under the IND, at 
236  sites at which investigators cannot or will not sign Form FDA 1572.   
237   
238  As explained in detail within this section, it is important that the sponsor establish an alternative 
239  course of action, acceptable to FDA, that will ensure that the investigator complies with 
240  commitments equivalent to those listed on Form FDA 1572.   
241   
242  45.  Is the waiver of the 1572 signature requirement a distinctly different waiver than an IRB 
243  requirement waiver? 
244  [New 2021] 
245   
246  Yes, they are distinct waivers.  Waiving the 1572 signature requirement does not waive the IRB 
247  requirement, and a waiver of the IRB requirement under 21 CFR 56.105 does not waive the 1572 
  6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
248  signature requirement.  If a sponsor wishes to request a waiver of the IRB requirement, refer to 
249  question 12.6   
250   
251  If a request for waiver of the 1572 signature includes the use of an independent ethics committee 
252  (IEC) instead of an IRB, then the sponsor should obtain IRB waiver approval first or submit both 
253  waiver requests in one submission.  FDA recommends that if a sponsor intends to request both a 
254  waiver of the 1572 signature requirement and a waiver of the IRB requirement, the sponsor does 
255  so in one submission.  In this submission, the sponsor should: 
256   
257  1.  Explicitly state, in the cover letter subject line, that it is requesting both waivers 
258  (waiver of the Form FDA 1572 signature and waiver of the IRB requirement); and 
259   
260  2.  Ensure that both the request for waiver of the 1572 signature requirement and the 
261  request for waiver of the IRB requirement contain all information required to support 
262  each waiver request.  The information supporting these requests should be separated 
263  and clearly marked. 
264   
265  46.  Are there any special considerations regarding Form FDA 1572 signature waivers and 
266  pediatric studies?   
267  [New 2021] 
268   
269  Sponsors requesting waivers of the Form FDA 1572 signature requirement for IND studies that 
270  include pediatric subjects at foreign sites should take into consideration that any study that 
271  includes pediatric patients must demonstrate that the proposed study satisfies the requirements of 
272  21 CFR part 50, subpart D.  We recommend sponsors consult with FDA regarding any such 
273  request for a waiver under 21 CFR 312.10, as needed.  
 
6 See question 12 in the information sheet guidance for sponsors, clinical investigators, and IRBs Frequently Asked 
QuestionsStatement of Investigator (Form FDA 1572). 
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Draft  Not for Implementation 
274   
275  APPENDIX:  EXAMPLES OF SPONSOR AND INVESTIGATOR COMMITMENTS  
276  [New 2021] 
277   
278    
279  SPONSOR COMMITMENT (EXAMPLE) 
280   
281  Sponsor XYZ declares that all the study sites under IND XXXX for which a waiver of the 1572 
282  signature requirement is requested will be conducted in a country where the national regulatory 
283  authority is a member of the International Council for Harmonisation of Technical Requirements 
284  for Pharmaceuticals for Human Use (ICH).  The country has implemented the ICH E6 Guideline 
285  for Good Clinical Practice (ICH E6) in regional and/or national legislation, norms, regulations, 
286  or competent authority administrative processes. 
287   
288  Sponsor XYZ will obtain a signed commitment to follow the recommendations in ICH E6 from 
289  each investigator at the study sites listed, using the form or template accepted by the FDA when 
290  granting the waiver request.  Additionally, Sponsor XYZ will comply with the terms of the 
291  waiver.  Further, Sponsor XYZ will ensure that each investigator at the study sites listed 
292  complies with the commitments contained in this waiver request. 
293   
294   
295  Signature and date: ___________________________ 
296   
297   
298  INVESTIGATOR COMMITMENTS (EXAMPLE)  
299  [New 2021] 
300   
301  This study will be conducted consistent with the recommendations in ICH E6 Guideline for 
302  Good Clinical Practice1 and all regional, national, or local regulations:  
303   
304  1.  I agree to conduct the study or studies in accordance with the relevant, current protocol(s) 
305  and will only make changes in a protocol after receiving approval from the sponsor, 
306  except when necessary to protect the safety, rights, or welfare of subjects. 
307   
308  2.  I agree to personally conduct or supervise the described investigation(s). 
309   
310  3.  I agree to inform any participants or any persons who serve in the clinical trial that the 
311  drugs are being used for investigational purposes, and I will ensure that the requirements 
312  relating to obtaining informed consent and institutional review board (IRB) or 
313  independent ethics committee (IEC) review and approval are met in accordance with 
314  national and regional legislation and the Declaration of Helsinki, and consistent with the 
315  recommendations in ICH E6. 
316   
317  4.  I agree to report to the sponsor adverse events that occur in the course of the 
318  investigation(s) in accordance with national and regional legislation and the Declaration 
 
1 Refer to the most updated revisions of this guideline at https://www.ich.org/page/efficacy-guidelines. 
  8  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
319  of Helsinki, and consistent with the recommendations in ICH E6.  I have read and 
320  understand the information in the investigators brochure, including the potential risks 
321  and side effects of the drug. 
322   
323  5.  I agree to ensure that all associates, colleagues, and employees assisting in the conduct of 
324  the study or studies are informed about their obligations in meeting the investigator 
325  commitments in items 1 through 4 above. 
326   
327  6.  I agree to maintain adequate and accurate records and to make those records available for 
328  inspection in accordance with national and regional legislation and the Declaration of 
329  Helsinki, and consistent with the recommendations in ICH E6. 
330   
331  7.  I will ensure that an IRB or an IEC that complies with the requirements of national and 
332  regional legislation and the Declaration of Helsinki, and that follows the 
333  recommendations in ICH E6, will be responsible for the initial and continuing review and 
334  approval of the clinical investigation.  I also agree to promptly report to the IEC all 
335  changes in research activity and all unanticipated problems involving risks to human 
336  subjects or others.  Additionally, I will not make any changes in the research without IEC 
337  approval, except where necessary to eliminate apparent immediate hazards to human 
338  subjects. 
339   
340  8.  I agree to comply with all other requirements regarding obligations of clinical 
341  investigators and with all other pertinent requirements in accordance with national and 
342  regional legislation and the Declaration of Helsinki.  I also agree to follow the 
343  recommendations in ICH E6. 
344   
345   
346   
347  Signature and date: ______________________________ 
348   
349   
  9