Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1): Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1)

Administrative draft guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

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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DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft
guidance.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

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., 4 th 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
10903 New Hampshire Ave., Bldg. 71, Room 3128
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

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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 investigator’s
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 FDA’s IND requirements under 21 CFR part 312? .... 3
IV. 	SECTION #9–11: 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

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Information Sheet Guidance	1
for Sponsors, Clinical Investigators, and IRBs1
2
Frequently Asked Questions	3
Statement of Investigator (Form FDA 1572) (Revision 1)	4
5
6
7
This draft guidance, when finalized, will represent the current thinking of the Food and Drug	8
Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not	9
binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the	10
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible	11
for this guidance as listed on the title page.	12
13
14
15
16
I. 	INTRODUCTION	17
18
This guidance is intended to assist sponsors, clinical investigators, and institutional review boards	19
(IRBs) involved in clinical investigations of investigational drugs and biological products. This	20
guidance applies to clinical investigations conducted under 21 CFR part 312 (investigational new	21
drug application (IND) regulations) and describes how to complete the Statement of Investigator	22
(Form FDA 1572).	23
24
25
II. 	BACKGROUND	26
27
FDA has received questions about Form FDA 1572. The most frequently asked questions	28
(FAQs) are answered in the information sheet guidance for sponsors, clinical investigators, and	29
IRBs Frequently Asked Questions—Statement of Investigator (Form FDA 1572) (May 2010)2 (the	30
Form FDA 1572 FAQ Guidance).	31
32
This guidance, when finalized, partially revises the Form FDA 1572 FAQ Guidance and answers	33
additional questions received by FDA. Questions not answered either in this guidance or in the	34
Form FDA 1572 FAQ Guidance may be submitted to druginfo@fda.hhs.gov.	35
36
This guidance has been developed in response to multiple inquiries regarding waivers of the	37
signature requirement on Form FDA 1572 and, when finalized, will explain FDA’s current	38
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.

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thinking regarding signature waivers. Specifically, this draft guidance revises general questions	39
10, 11, and 13 from the Form FDA 1572 FAQ Guidance and includes a new section (see	40
questions 39 through 46) about waivers of the Form FDA 1572 signature requirement.	41
42
The contents of this document do not have the force and effect of law and are not meant to bind	43
the public in any way, unless specifically incorporated into a contract. This document is	44
intended only to provide clarity to the public regarding existing requirements under the law.	45
FDA guidance documents, including this guidance, should be viewed only as recommendations,	46
unless specific regulatory or statutory requirements are cited. The use of the word should in	47
Agency guidances means that something is suggested or recommended, but not required.	48
49
50
III. 	GENERAL QUESTIONS (10, 11, AND 13)	51
52
10. Must investigators who conduct studies outside of the United States sign a 1572?	53
[Revised 2021]	54
55
If a clinical study is conducted at a foreign site under an IND, all FDA IND regulations,	56
including the requirement to obtain a signed 1572 (21 CFR 312.53(c)(1)), must be met unless	57
the sponsor requests and is granted a waiver that provides for specific exceptions. In the case	58
where a foreign investigator cannot or will not sign Form FDA 1572 (e.g., because regional,	59
national, or local laws or regulations prohibit its signing), the sponsor may submit a request for	60
a waiver of the 1572 signature requirement under 21 CFR 312.10 (see section [IV] of this	61
guidance); alternatively, the site may operate as a non-IND site, in which case the study would	62
be conducted as a non-IND study.	63
64
If a clinical study is conducted outside of the United States and the study is not under an IND,	65
then the investigator need not sign a 1572. If the study data from a non-IND site is to be	66
submitted to support a marketing application (e.g., a new drug application (NDA)), the study at	67
the non-IND site must be conducted in compliance with 21 CFR 312.120. (Also, see question	68
14 in the Form FDA 1572 FAQ Guidance.)	69
70
11. If a foreign clinical study is being conducted under an IND, what are the investigator’s	71
responsibilities with respect to regional, national, or local laws and regulations?	72
[Revised 2021]	73
74
Investigators are responsible for complying with the applicable laws and regulations of the	75
country in which the study is being conducted, regardless of whether the study is being	76
conducted under an IND. We recommend that sponsors obtain signed, written statements from	77
investigators acknowledging their commitment to comply with regional, national, or local laws	78
and requirements. In addition, if a foreign clinical study is being conducted under an IND, the	79
investigator must sign Form FDA 1572 (investigator statement) (21 CFR 312.53(c)(1)) and	80
ensure that the study is conducted in accordance with the investigator statement and all other	81
applicable regulations under 21 CFR part 312 unless the sponsor has requested, and FDA has	82
granted, a waiver of the signature requirement. If a waiver is granted, the sponsor and	83

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investigator must ensure that the study is conducted in accordance with the terms of the waiver.	84
(See section [IV] of this guidance.)	85
86
13. If a sponsor chooses to conduct a foreign clinical study (or operate non-U.S. sites in a	87
multinational study) under an IND and the investigators at these non-U.S. sites follow the	88
recommendations in the ICH E6 Good Clinical Practice Consolidated Guidance,3 would the	89
non-U.S. investigators also be in compliance with FDA’s IND requirements under 21 CFR	90
part 312?	91
[Revised 2021]	92
93
Yes, with three exceptions.	94
95
The first exception is that the FDA requirements for IRBs under 21 CFR part 56 are slightly	96
different than ICH E6 with respect to membership and function. To address this issue, as	97
described in question 12,4 the sponsor can request that FDA provide a specific waiver from the	98
part 56 IRB requirements, allowing an IEC that complies with good clinical practice to substitute	99
for the IRB.5	
100
101
The second exception is that the requirements for informed consent under 21 CFR part 50 for	102
particular clinical trials (e.g., emergency research under 21 CFR 50.24, clinical investigations	103
involving pediatric subjects under subpart D) are more extensive than ICH E6 with respect to	104
IRB responsibilities. Our experience has not revealed that this difference has caused a conflict,	105
but in the event of one, we would be willing to discuss a resolution with the sponsor on a case-	106
by-case basis.	107
108
The third exception is that ICH E6 does not require investigators to sign a Form FDA 1572. To	109
address this issue, the sponsor can request a specific waiver of the signature requirement on	110
Form FDA 1572 pursuant to 21 CFR 312.10. (See section [IV] of this guidance.)	111
112
If the investigator or sponsor concludes that there are other conflicting requirements, the sponsor	113
may request a waiver from FDA from the specific requirement under 21 CFR 312.10.	114
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
Questions—Statement 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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IV. 	SECTION #9–11: COCOMMITMENTS, DATE, AND SIGNATURE OF	117
INVESTIGATOR — WAIVER OF SIGNATURE ON FORM FDA 1572	118
119
39. A sponsor may encounter situations in which investigators in foreign countries cannot or	120
will not sign Form FDA 1572, yet the sponsor wishes to conduct the study at these sites under	121
an IND. What can a sponsor do?	122
[New 2021]	123
124
Under FDA regulations, sponsors may submit requests to FDA for a waiver of an IND	125
requirement (21 CFR 312.10). Such submissions may include request for a waiver of the	126
requirement that sponsors obtain an investigator signature on Form FDA 1572 (21 CFR 312.53	127
(c)(1)). Waiver of the signature on Form FDA 1572, when granted, enables the study at foreign	128
sites to be and/or remain under an IND even though the investigator at those foreign sites cannot	129
or will not sign Form FDA 1572, provided that the sponsor complies with the terms of the	130
waiver. (See below for further information regarding the waiver process and commitments.)	131
132
40. What should a sponsor submit to the IND when requesting a waiver of the 1572 signature	133
requirement?	134
[New 2021]	135
136
1. 	A clear statement that the sponsor is requesting a waiver of the signature requirement on	137
the 1572	138
139
2. 	The study title, protocol number, study sites, and investigator name(s) that would be	140
subject to the waiver (Note: If multiple sites are identified, the submission should	141
identify which investigator(s) is associated with each site.)	142
143
A waiver request is required to contain at least one of the following (21 CFR 312.10(a)):	144
145
3. 	The reason(s) each investigator cannot or will not sign Form FDA 1572	146
147
4. 	The sponsor’s proposed alternative course of action to adequately satisfy the purpose of a	148
signed Form FDA 1572	149
150
5. 	Other information justifying a waiver	151
152
For FDA to consider granting the waiver request, it is important that the request addresses all of	153
the items above.	154
155
41. What documentation should a sponsor submit to show that they have an acceptable	156
alternative course of action to satisfy the purpose of a signed Form FDA 1572? Can you	157
provide an example?	158
[New 2021]	159
160

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There may be multiple ways for a sponsor to assure FDA that its alternative course of action	161
adequately satisfies the purpose of a signed Form FDA 1572. Although there may be other	162
approaches, FDA recommends using the example and suggested templates found in the	163
Appendix of this guidance, which will likely result in the most efficient review of the waiver	164
request.	165
166
An alternative course of action could take the form of the submission of the following three	167
items:	168
169
1. 	Declaration by the sponsor that the regional (in the case of the European Union) or	170
national regulatory authority is a member of the International Council for Harmonisation	171
of Technical Requirements for Pharmaceuticals for Human Use (ICH) and has	172
implemented the ICH E6 Guideline for Good Clinical Practice. In addition, a	173
determination by the sponsor that an investigator’s compliance with the ICH E6	174
Guideline for Good Clinical Practice will ensure that the investigator and sponsor comply	175
with their respective obligations under 21 CFR part 312, other than the signature	176
requirement on Form FDA 1572. (See the sponsor commitment example in the	177
appendix.)	178
179
2. 	Commitment by the sponsor to collect from each investigator for whom the signature	180
requirement was waived, a completed but unsigned Form FDA 1572 that includes all	181
information in sections 1 through 8 of Form FDA 1572 and a signed statement containing	182
commitments equivalent to the commitments specified in Section 9 of Form FDA 1572.	183
(Note: In place of Form FDA 1572, the sponsor may choose to use an appropriate	184
alternative template of its choice.) (See the sponsor commitment example in the	185
appendix.)	186
187
3. 	Any templates or forms the sponsor intends to use to collect information and/or secure	188
signed commitments from the applicable investigators. (See the investigator commitment	189
example in the appendix.)	190
191
We encourage sponsors considering other approaches to discuss these with the appropriate	192
review division.	193
194
42. How and when should a sponsor submit the request to waive the signature requirement?	195
[New 2021]	196
197
The sponsor should submit the waiver request along with the necessary documentation	198
supporting the waiver request in an amendment to the IND under which the study will be	199
conducted.	200
201
The sponsor should submit the request to waive the signature on Form FDA 1572 when it	202
determines that an investigator(s) cannot or will not sign Form FDA 1572.	203
204

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If after a waiver request is granted, new investigators are added to this IND protocol who refuse	205
or cannot sign the Form FDA 1572 and the sponsor wants to request a waiver of the Form FDA	206
1572 signature requirement, they will need to submit a new waiver request applicable to these	207
new investigators (21 CFR 312.53(c)(1); 21 CFR 312.10)). When doing so, the sponsor should	208
reference the protocol number, the date of the original request, and the date of any previous	209
correspondence with FDA regarding the original waiver in a cover letter.	210
211
43. Does the sponsor need to wait for the waiver request to be granted before initiating the	212
study at that site?	213
[New 2021]	214
215
Yes. The Agency will inform the sponsor in writing whether the Agency is granting each	216
request to waive the 1572 signature requirement under 21 CFR 312.10(b), whether the request	217
requires more information, or whether the request is denied. Only after either receiving a	218
granted 1572 signature waiver or obtaining an appropriately signed Form FDA 1572 may a	219
sponsor initiate the study at that site.	220
221
The sponsor should not assume that no response or a delayed response from the Agency means	222
that the request for waiver has been granted.	223
224
If a waiver is granted, the sponsor should ensure that a copy of the waiver is maintained by the	225
sponsor and the investigator so that it is available for review upon request.	226
227
44. What does it mean to get a “1572 signature waiver”?	228
[New 2021]	229
230
The waiver does not waive the sponsor’s obligation to ensure that the investigator complies with	231
the equivalent commitments expressed in the waiver request. Likewise, the waiver does not	232
waive the sponsor’s obligation to comply with all other applicable regulations.	233
234
Instead, after the Agency grants the waiver, the sponsor can conduct the study, under the IND, at	235
sites at which investigators cannot or will not sign Form FDA 1572.	236
237
As explained in detail within this section, it is important that the sponsor establish an alternative	238
course of action, acceptable to FDA, that will ensure that the investigator complies with	239
commitments equivalent to those listed on Form FDA 1572.	240
241
45. Is the waiver of the 1572 signature requirement a distinctly different waiver than an IRB	242
requirement waiver?	243
[New 2021]	244
245
Yes, they are distinct waivers. Waiving the 1572 signature requirement does not waive the IRB	246
requirement, and a waiver of the IRB requirement under 21 CFR 56.105 does not waive the 1572	247

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signature requirement. If a sponsor wishes to request a waiver of the IRB requirement, refer to	248
question 12.6	
249
250
If a request for waiver of the 1572 signature includes the use of an independent ethics committee	251
(IEC) instead of an IRB, then the sponsor should obtain IRB waiver approval first or submit both	252
waiver requests in one submission. FDA recommends that if a sponsor intends to request both a	253
waiver of the 1572 signature requirement and a waiver of the IRB requirement, the sponsor does	254
so in one submission. In this submission, the sponsor should:	255
256
1. 	Explicitly state, in the cover letter subject line, that it is requesting both waivers	257
(waiver of the Form FDA 1572 signature and waiver of the IRB requirement); and	258
259
2. 	Ensure that both the request for waiver of the 1572 signature requirement and the	260
request for waiver of the IRB requirement contain all information required to support	261
each waiver request. The information supporting these requests should be separated	262
and clearly marked.	263
264
46. Are there any special considerations regarding Form FDA 1572 signature waivers and	265
pediatric studies?	266
[New 2021]	267
268
Sponsors requesting waivers of the Form FDA 1572 signature requirement for IND studies that	269
include pediatric subjects at foreign sites should take into consideration that any study that	270
includes pediatric patients must demonstrate that the proposed study satisfies the requirements of	271
21 CFR part 50, subpart D. We recommend sponsors consult with FDA regarding any such	272
request for a waiver under 21 CFR 312.10, as needed.	273
6 See question 12 in the information sheet guidance for sponsors, clinical investigators, and IRBs Frequently Asked
Questions—Statement of Investigator (Form FDA 1572).

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274
APPENDIX: EXAMPLES OF SPONSOR AND INVESTIGATOR COMMITMENTS	275
[New 2021]	276
277
278
SPONSOR COMMITMENT (EXAMPLE)	279
280
Sponsor XYZ declares that all the study sites under IND XXXX for which a waiver of the 1572	281
signature requirement is requested will be conducted in a country where the national regulatory	282
authority is a member of the International Council for Harmonisation of Technical Requirements	283
for Pharmaceuticals for Human Use (ICH). The country has implemented the ICH E6 Guideline	284
for Good Clinical Practice (ICH E6) in regional and/or national legislation, norms, regulations,	285
or competent authority administrative processes.	286
287
Sponsor XYZ will obtain a signed commitment to follow the recommendations in ICH E6 from	288
each investigator at the study sites listed, using the form or template accepted by the FDA when	289
granting the waiver request. Additionally, Sponsor XYZ will comply with the terms of the	290
waiver. Further, Sponsor XYZ will ensure that each investigator at the study sites listed	291
complies with the commitments contained in this waiver request.	292
293
294
Signature and date: ___________________________	295
296
297
INVESTIGATOR COMMITMENTS (EXAMPLE)	298
[New 2021]	299
300
This study will be conducted consistent with the recommendations in ICH E6 Guideline for	301
Good Clinical Practice1 and all regional, national, or local regulations:	302
303
1. 	I agree to conduct the study or studies in accordance with the relevant, current protocol(s)	304
and will only make changes in a protocol after receiving approval from the sponsor,	305
except when necessary to protect the safety, rights, or welfare of subjects.	306
307
2. 	I agree to personally conduct or supervise the described investigation(s).	308
309
3. 	I agree to inform any participants or any persons who serve in the clinical trial that the	310
drugs are being used for investigational purposes, and I will ensure that the requirements	311
relating to obtaining informed consent and institutional review board (IRB) or	312
independent ethics committee (IEC) review and approval are met in accordance with	313
national and regional legislation and the Declaration of Helsinki, and consistent with the	314
recommendations in ICH E6.	315
316
4. 	I agree to report to the sponsor adverse events that occur in the course of the	317
investigation(s) in accordance with national and regional legislation and the Declaration	318
1 Refer to the most updated revisions of this guideline at https://www.ich.org/page/efficacy-guidelines.

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of Helsinki, and consistent with the recommendations in ICH E6. I have read and	319
understand the information in the investigator’s brochure, including the potential risks	320
and side effects of the drug.	321
322
5. 	I agree to ensure that all associates, colleagues, and employees assisting in the conduct of	323
the study or studies are informed about their obligations in meeting the investigator	324
commitments in items 1 through 4 above.	325
326
6. 	I agree to maintain adequate and accurate records and to make those records available for	327
inspection in accordance with national and regional legislation and the Declaration of	328
Helsinki, and consistent with the recommendations in ICH E6.	329
330
7. 	I will ensure that an IRB or an IEC that complies with the requirements of national and	331
regional legislation and the Declaration of Helsinki, and that follows the	332
recommendations in ICH E6, will be responsible for the initial and continuing review and	333
approval of the clinical investigation. I also agree to promptly report to the IEC all	334
changes in research activity and all unanticipated problems involving risks to human	335
subjects or others. Additionally, I will not make any changes in the research without IEC	336
approval, except where necessary to eliminate apparent immediate hazards to human	337
subjects.	338
339
8. 	I agree to comply with all other requirements regarding obligations of clinical	340
investigators and with all other pertinent requirements in accordance with national and	341
regional legislation and the Declaration of Helsinki. I also agree to follow the	342
recommendations in ICH E6.	343
344
345
346
Signature and date: ______________________________	347
348
349